Roche Diagnostics Operations, Inc.
Medical device manufacturer in Indianapolis, IN.
7510(k) clearances
2PMA approvals
151recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | 01/24/2025SE |
| K233454 | ONLINE TDM MethotrexateLAO · Traditional | 02/20/2024SE |
| K163633 | cobas HbA1c Test, cobas b 101 systemLCP · Traditional | 07/28/2017SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | 10/11/2013SE |
| K131029 | Accu-Chek Aviva Plus Test StripNBW · Special | 08/09/2013SE |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX GEN.3 AssayPDJ · Traditional | 08/08/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | 05/14/2012SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1476-2026 Class II | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample…Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type… | 01/20/2026Open, Classified |
| Z-1009-2026 Class II | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with…Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may… | 11/21/2025Open, Classified |
| Z-0489-2025 Class II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on…Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can… | 10/17/2024Open, Classified |
| Z-3187-2024 Class II | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro…Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus… | 08/15/2024Open, Classified |
| Z-0352-2024 Class II | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material…Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. | 10/03/2023Open, Classified |
| Z-0952-2023 Class II | cobas infinity central lab, Material Number 07154003001A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability… | 12/12/2022Open, Classified |
| Z-1515-2022 Class II | cobas e801 Immunoassay AnalyzerSoftware issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following… | 07/14/2022Open, Classified |
| Z-0266-2022 Class II | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601…A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L… | 10/18/2021Terminated |
| Z-2444-2021 Class II | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#:…Under specific circumstances created by the user, the cobas e flow test results could be replaced by an… | 06/24/2021Terminated |
| Z-1675-2021 Class II | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 -…Roche received several complaints regarding increased control recovery and discrepant elevated results for… | 04/26/2021Open, Classified |
| Z-1596-2021 Class II | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in…Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an… | 04/07/2021Open, Classified |
| Z-1595-2021 Class II | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to…Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an… | 04/07/2021Open, Classified |
| Z-1098-2021 Class II | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of…May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of… | 01/06/2021Terminated |
| Z-0883-2021 Class II | A calculator/data processing module for clinical use is an electronic device intended to…A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent… | 12/17/2020Terminated |
| Z-0755-2021 Class II | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801…Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated… | 12/08/2020Open, Classified |
| Z-0754-2021 Class II | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701…Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated… | 12/08/2020Open, Classified |
| Z-0804-2021 Class II | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for…Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing… | 12/02/2020Terminated |
| Z-0803-2021 Class II | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for…Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing… | 12/02/2020Terminated |
| Z-0752-2021 Class II | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete)…During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be… | 11/23/2020Terminated |
| Z-0634-2021 Class II | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in…Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant… | 11/06/2020Terminated |
| Z-0461-2021 Class II | cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions…Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control… | 10/09/2020Terminated |
| Z-0086-2021 Class II | DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number:…Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket… | 08/31/2020Open, Classified |
| Z-0085-2021 Class II | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket… | 08/31/2020Open, Classified |
| Z-0104-2021 Class III | Albumin Gen.2, Catalog 05166861190Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the… | 08/27/2020Terminated |
| Z-0103-2021 Class III | Tina-quant Complement C4 ver.2, Catalog 05991994190Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the… | 08/27/2020Terminated |
| Z-2981-2020 Class II | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190Recent internal verification studies found the current RF interference claim to no longer be met for the… | 08/20/2020Terminated |
| Z-1444-2020 Class II | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for…The firm has received an increased number of complaints concerning non-reproducible elevated results ("high… | 02/07/2020Terminated |
| Z-1158-2020 Class II | cobas infinity core, Material No. 7154003001. The device is a calculator/data processing…Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation… | 01/07/2020Terminated |
| Z-0669-2020 Class II | Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to…Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border… | 10/28/2019Terminated |
| Z-0922-2020 Class II | Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing…Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect… | 10/08/2019Terminated |
| Z-0679-2020 Class II | Roche Homocysteine-In vitro test for the quantitative determination of total…Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules | 10/04/2019Terminated |
| Z-0153-2020 Class III | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test…Due to low Quality Control recovery and invalid Calibration. | 09/11/2019Terminated |
| Z-0152-2020 Class III | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product…Due to low Quality Control recovery and invalid Calibration. | 09/11/2019Terminated |
| Z-0109-2020 Class II | cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog…Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference | 08/28/2019Terminated |
| Z-0108-2020 Class II | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference…Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference | 08/28/2019Terminated |
| Z-0044-2020 Class II | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c…AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal… | 08/13/2019Terminated |
| Z-0043-2020 Class II | Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c…Inaccurately Low Sample Results | 07/23/2019Terminated |
| Z-0042-2020 Class II | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c…Inaccurately Low Sample Results | 07/23/2019Terminated |
| Z-2478-2019 Class II | cobas c513 AnalyzerQuality issue with high pressure solenoid valves | 07/18/2019Terminated |
| Z-2477-2019 Class II | Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001…Quality issue with high pressure solenoid valves | 07/18/2019Terminated |
| Z-2476-2019 Class II | cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001Quality issue with high pressure solenoid valves may cause inaccurate results. | 07/18/2019Terminated |
| Z-2362-2019 Class II | Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR… | 07/16/2019Terminated |
| Z-2361-2019 Class II | Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR… | 07/16/2019Terminated |
| Z-2445-2019 Class II | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the…The firm conducted internal investigations that confirmed customer complaints of quality control (QC)… | 07/02/2019Terminated |
| Z-0673-2017 Class II | MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b…Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be… | 10/31/2016Terminated |
| Z-0396-2017 Class II | COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number….Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant… | 10/04/2016Terminated |
| Z-0395-2017 Class II | Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 /…Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin… | 10/04/2016Terminated |
| Z-0387-2017 Class II | Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use…cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and… | 09/27/2016Terminated |
| Z-0110-2017 Class II | cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0109-2017 Class II | cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0108-2017 Class II | cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0107-2017 Class II | cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0106-2017 Class II | cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0105-2017 Class II | RSD 800 Sorting System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0104-2017 Class II | RSD 800A Aliquoting System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0103-2017 Class II | VS II Aliquoter System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0102-2017 Class II | cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0101-2017 Class II | cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0100-2017 Class II | Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0099-2017 Class II | URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0098-2017 Class II | Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0097-2017 Class II | cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0096-2017 Class II | cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use.…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0095-2017 Class II | cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0094-2017 Class II | Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-2304-2016 Class II | ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin…Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the… | 05/26/2016Terminated |
| Z-1277-2016 Class II | Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL…Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used… | 03/07/2016Terminated |
| Z-1276-2016 Class II | Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9…Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used… | 03/07/2016Terminated |
| Z-1092-2017 Class II | Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The…Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number… | 02/26/2016Terminated |
| Z-1233-2016 Class II | cobas p 512 pre-analytical system Pre-analytical sample handling that includes…Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly… | 02/23/2016Terminated |
| Z-1172-2016 Class II | Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose…Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the… | 02/11/2016Terminated |
| Z-0297-2016 Class II | Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes…Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples… | 09/22/2015Terminated |
| Z-1077-2017 Class II | Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for…under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on… | 09/03/2015Terminated |
| Z-2447-2015 Class II | cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC…Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a… | 07/14/2015Terminated |
| Z-2446-2015 Class II | cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC…Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a… | 07/14/2015Terminated |
| Z-2330-2015 Class II | S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and…The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b… | 06/24/2015Terminated |
| Z-1931-2015 Class II | Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1930-2015 Class II | Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1929-2015 Class II | Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1928-2015 Class II | LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1927-2015 Class II | LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1926-2015 Class II | Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1925-2015 Class II | HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1924-2015 Class II | HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1923-2015 Class II | Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1922-2015 Class II | Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1921-2015 Class II | Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1920-2015 Class II | Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | 05/07/2015Terminated |
| Z-1622-2015 Class II | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests…Customers complained about under-recovery of non-Roche controls and discrepant low patient results with… | 03/23/2015Terminated |
| Z-1041-2015 Class II | Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes AnalyzerChemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up… | 12/18/2014Terminated |
| Z-0894-2015 Class II | ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0893-2015 Class II | ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0892-2015 Class II | ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0891-2015 Class II | ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0890-2015 Class II | ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0889-2015 Class II | ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0888-2015 Class II | ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0887-2015 Class II | ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0886-2015 Class II | ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0885-2015 Class II | ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0884-2015 Class II | ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0883-2015 Class II | ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion…Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender… | 11/20/2014Terminated |
| Z-0146-2015 Class II | ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System…The insulin pump may lose time and date settings during a power interruption (such as a battery change) due… | 09/25/2014Terminated |
| Z-0064-2015 Class III | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics…The default references for normal values are inconsistent between cobas b 221 and other blood gas… | 09/12/2014Terminated |
| Z-2563-2014 Class II | Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store…Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT… | 07/31/2014Terminated |
| Z-1792-2014 Class II | cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No…Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant… | 05/21/2014Terminated |
| Z-1791-2014 Class II | cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat.…Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant… | 05/21/2014Terminated |
| Z-1790-2014 Class II | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version…Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant… | 05/21/2014Terminated |
| Z-1616-2014 Class II | ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count…Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low… | 04/14/2014Terminated |
| Z-1449-2014 Class II | Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical…The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000… | 03/13/2014Terminated |
| Z-1315-2014 Class II | Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part…Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause… | 02/28/2014Terminated |
| Z-0385-2014 Class II | ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo…There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual… | 10/25/2013Terminated |
| Z-0168-2014 Class II | COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001…Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions.… | 09/16/2013Terminated |
| Z-2109-2013 Class II | ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood…Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may… | 08/19/2013Terminated |
| Z-1584-2013 Class II | CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | 05/16/2013Terminated |
| Z-1583-2013 Class II | CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | 05/16/2013Terminated |
| Z-1582-2013 Class II | CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | 05/16/2013Terminated |
| Z-1581-2013 Class II | CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | 05/16/2013Terminated |
| Z-1727-2013 Class II | B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in…Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the… | 04/25/2013Terminated |
| Z-1368-2013 Class II | Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the…When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead… | 04/04/2013Terminated |
| Z-1114-2013 Class II | CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the…Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading… | 03/06/2013Terminated |
| Z-1113-2013 Class II | ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the…Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading… | 03/06/2013Terminated |
| Z-1028-2013 Class II | Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number…Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a… | 03/01/2013Terminated |
| Z-0696-2013 Class III | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied… | 11/19/2012Terminated |
| Z-0522-2013 Class II | Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole…It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171… | 11/14/2012Terminated |
| Z-0473-2013 Class II | Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas…On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent… | 11/01/2012Terminated |
| Z-1388-2012 | Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of…An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I… | 03/12/2012Terminated |
| Z-1387-2012 | Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac…An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I… | 03/12/2012Terminated |
| Z-1386-2012 | ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied…Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a… | 03/12/2012Terminated |
| Z-1218-2012 | Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for…Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after… | 01/31/2012Terminated |
| Z-0310-2012 | cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of…The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte… | 10/26/2011Terminated |
| Z-0311-2012 | Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic…Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one… | 10/18/2011Terminated |
| Z-3078-2011 | MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations…Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0… | 07/21/2011Terminated |
| Z-3077-2011 | MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An…Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0… | 07/21/2011Terminated |
| Z-2570-2011 | ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS…Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that… | 05/18/2011Terminated |
| Z-1680-2011 | Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322…The current product labeling for Acetaminophen does not provide specific interference information for… | 12/07/2010Terminated |
| Z-1679-2011 | Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche…The current product labeling for Acetaminophen does not provide specific interference information for… | 12/07/2010Terminated |
| Z-1653-2011 | Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The…If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct… | 10/26/2010Terminated |
| Z-1652-2011 | Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics…If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct… | 10/26/2010Terminated |
| Z-1651-2011 | MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics…If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct… | 10/26/2010Terminated |
| Z-1824-2011 | Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche…Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant… | 10/11/2010Terminated |
| Z-1823-2011 | Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS…The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS… | 10/11/2010Terminated |
| Z-1998-2011 | Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH…The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date. | 08/13/2010Terminated |
| Z-2386-2010 | ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent…The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct… | 02/05/2010Terminated |
| Z-0972-2010 | Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | 10/07/2009Terminated |
| Z-0971-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | 10/07/2009Terminated |
| Z-0970-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | 10/07/2009Terminated |
| Z-2004-2009 | Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | 07/22/2009Terminated |
| Z-2003-2009 | Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | 07/22/2009Terminated |
| Z-2002-2009 | Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | 07/22/2009Terminated |
| Z-0536-2014 Class II | MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated…This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software… | 11/25/0013Terminated |