Immunoassay Method, Troponin Subunit
FDA product code MMI · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
95510(k) clearances
0PMA approvals
48recalls
Manufacturers
- Beckman Coulter Inc. 10
- Dade Behring, Inc. 7
- Boehringer Mannheim Corp. 6
- Siemens Healthcare Diagnostics, Inc. 6
- Roche Diagnostics Corp. 6
- Ortho-Clinical Diagnostics 6
- Bayer Corp. 4
- Spectral Diagnostics, Inc. 4
- Princeton BioMeditech Corp. 3
- Abbott Laboratories Diagnostics Division 3
- Abbott Laboratories 3
- Nano-Ditech Corporation 3
- First Medical, Inc. 3
- BioCheck Inc 2
- Tosoh Medics, Inc. 2
- Diagnostic Products Corp. 2
- Vancouver Biotech , Ltd. 2
- Biomerieux Inc 2
- Bayer Healthcare, LLC 2
- Abbott Point Of Care Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | Abbott Point of Care, Inc. | 06/11/2026SE |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/29/2025SE |
| K243483 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 08/01/2025SE |
| K242870 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 06/16/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | Abbott Point of Care, Inc. | 01/03/2025SE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2024SE |
| K231974 | PATHFAST®hs-cTnI-IIMMI · Traditional | Phc Corporation | 03/20/2024SE |
| K222881 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/04/2023SE |
| K230994 | Alinity i STAT High Sensitivity Troponin-IMMI · Special | Abbott Laboratories Diagnostics Division | 05/04/2023SE |
| K202525 | Alinity i STAT High Sensitivity Troponin-IMMI · Traditional | Abbott Laboratories Diagnostics Division | 05/19/2022SE |
| K201441 | Elecsys Troponin T Gen 5MMI · Traditional | Roche Diagnostics | 09/21/2021SE |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-IMMI · Traditional | Abbott Laboratories Diagnostics Division | 09/13/2019SE |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) AssayMMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/17/2019SE |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) AssayMMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/04/2019SE |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/19/2018SE |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/12/2018SE |
| K172787 | Access hsTnlMMI · Traditional | Beckman Coulter, Inc. | 06/14/2018SE |
| K172783 | Access hs TnlMMI · Traditional | Beckman Coulter, Inc. | 06/12/2018SE |
| K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…MMI · Traditional | Roche Diagnostics | 01/18/2017SE |
| K121790 | Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay…MMI · Traditional | Beckman Coulter, Inc. | 09/25/2013SE |
| K121214 | Access ACCUTNI+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…MMI · Traditional | Beckman Coulter, Inc. | 06/14/2013SE |
| K100130 | Pathfast Ctni-Ii Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2MMI · Traditional | Mitsubishi Chemical Medience CO | 05/16/2011SE |
| K102441 | Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and MyoglobinMMI · Special | Nano-Ditech Corporation | 10/20/2010SE |
| K102131 | Nano-Check Ami Ctni Cardiac Marker TestMMI · Special | Nano-Ditech Corporation | 10/20/2010SE |
| K082699 | Elecsys Troponin I and Troponin I Stat Test SystemsMMI · Traditional | Roche Diagnostics | 08/19/2009SE |
| K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692MMI · Special | Siemens Healthcare Diagnostics | 07/03/2008SE |
| K063243 | Vidas Troponin I Ultra (Tniu) Assay, Model 30 448MMI · Traditional | bioMerieux, Inc. | 12/14/2007SE |
| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | Fisher Diagnostics | 09/13/2007SE |
| K063756 | Dimension Vista Ctni Flex Reagent CartridgeMMI · Traditional | Dade Behring, Inc. | 03/19/2007SE |
| K062838 | Vitros Troponin I Es Assay, Including Reagent Pack, Calibrators and Range Verifiers…MMI · Traditional | Ortho-Clinical Diagnostics | 12/19/2006SE |
| K060875 | Abbott Axsym Troponin-I AdvMMI · Traditional | Abbott Laboratories | 06/14/2006SE |
| K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentMMI · Traditional | Dade Behring, Inc. | 04/14/2006SE |
| K050975 | Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…MMI · Traditional | Nano-Ditech Co. | 03/02/2006SE |
| K053020 | Tnl-Ultra Assay for the Advia Centaur SystemMMI · Traditional | Bayer Healthcare, LLC | 12/30/2005SE |
| K052503 | Troponin I Ultra Assay and Calibrator for the Advia Ims SystemMMI · Traditional | Bayer Healthcare, LLC | 12/14/2005SE |
| K051925 | Carestart Cardiac 3-IN-1 Troponin 1/CK-MB/MYOGLOBINMMI · Traditional | Access Bio Incorporate | 11/29/2005SE |
| K050644 | Vancouver Biotech Human Cardiac Troponin I Immunoassay Test KitMMI · Traditional | Vancouver Biotech , Ltd. | 08/17/2005SE |
| K051752 | Roche Elecsys Troponin T Stat (Short Turnaround Time)MMI · Special | Roche Diagnostics | 07/11/2005SE |
| K041619 | Bio Check Whole Blood/Plasma/Sermon Model #801116MMI · Traditional | Biocheck, Inc. | 12/17/2004SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | Alfa Scientific Designs, Inc. | 11/19/2004SE |
| K041811 | Abbott Axsym Troponin-I AdvMMI · Traditional | Abbott Laboratories | 09/10/2004SE |
| K041192 | Architect Stat Troponin-I ImmunoassayMMI · Traditional | Fisher Diagnostics | 08/12/2004SE |
| K040733 | Elecsys Troponin T Stat TestMMI · Traditional | Roche Diagnostics Corp. | 05/17/2004SE |
| K033745 | Ramp Troponin I AssayMMI · Traditional | Response Biomedical Corp. | 05/17/2004SE |
| K033487 | Stratus CS Acute Care Troponin I Testpak, Model CctniMMI · Traditional | Dade Behring, Inc. | 12/24/2003SE |
| K031031 | Vitros Immunodiagnostic Products Troponin I Reagent Pack and CalibratorsMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 09/29/2003SE |
| K031739 | I-Stat Cardiac Troponin (Ctni) TestMMI · Traditional | I-Stat Corporation | 09/02/2003SE |
| K030950 | Vidas Troponin I (Tni), Model 30 445MMI · Traditional | bioMerieux, Inc. | 06/16/2003SE |
| K023505 | VBL Serum Troponin I Test, Model 1001MMI · Traditional | Vancouver Biotech , Ltd. | 03/31/2003SE |
| K030057 | Spectral Cardiac Status Ck-Mb/Myoglobin/Troponin I 3-IN-1 TestMMI · Traditional | Spectral Diagnostics, Inc. | 03/19/2003SE |
| K024193 | Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/CalibratorsMMI · Traditional | Ortho-Clinical Diagnostics | 02/21/2003SE |
| K022946 | Lifesign Mi Myoglobin/Troponin I Rapid TestMMI · Traditional | Princeton BioMeditech Corp. | 10/08/2002SE |
| K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345MMI · Traditional | Beckman Coulter, Inc. | 09/27/2002SE |
| K020950 | Spectral's 2 in 1 (Tni-Myo)MMI · Traditional | Spectral Diagnostics, Inc. | 05/24/2002SE |
| K020662 | Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ CalibratorsMMI · Traditional | Ortho-Clinical Diagnostics | 04/12/2002SE |
| K014105 | Spectral's Troponin IMMI · Traditional | Spectral Diagnostics, Inc. | 02/01/2002SE |
| K013062 | Biocheck Human Cardiac Troponin-I Immunoassay Test KitMMI · Traditional | Biocheck, Inc. | 01/08/2002SE |
| K014024 | Modification to Alpha DX SystemMMI · Special | First Medical, Inc. | 12/18/2001SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | Tosoh Medics, Inc. | 12/14/2001SE |
| K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345MMI · Traditional | Beckman Coulter, Inc. | 06/05/2001SE |
| K010313 | Dimension Ctni Flex Reagent CartridgeMMI · Traditional | Dade Behring, Inc. | 04/20/2001SE |
| K010201 | Bayer Advia Ims SystemMMI · Traditional | Bayer Corp. | 03/29/2001SE |
| K010562 | Alpha DX SystemMMI · Special | First Medical, Inc. | 03/13/2001SE |
| K000784 | The Cardiac Reader SystemMMI · Traditional | Roche Diagnostics Corp. | 05/18/2000SE |
| K993353 | Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System)MMI · Traditional | Bayer Corp. | 12/06/1999SE |
| K993309 | Bayer Diagnostics ACS:180 and Advia Centaur Troponin I AssayMMI · Traditional | Bayer Corp. | 12/06/1999SE |
| K992366 | Vitros Immunodiagnostic Products Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/08/1999SE |
| K992127 | Cardioquant Troponin I TestMMI · Traditional | Spectral Diagnostics, Inc. | 10/04/1999SE |
| K991177 | Opus Troponin I (CTN) Test ModulesMMI · Traditional | Dade Behring, Inc. | 07/01/1999SE |
| K991795 | Immulite Turbo Troponin I, Models LSKTI1, LSKTI5MMI · Special | Diagnostic Products Corp. | 06/09/1999SE |
| K984359 | Aia-Pack Troponin I AssayMMI · Traditional | Tosoh Medics, Inc. | 12/23/1998SE |
| K984093 | Stratus (R) CS Cardiac Troponin I (Trop) TestpakMMI · Traditional | Dade Behring, Inc. | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | Boehringer Mannheim Corp. | 12/08/1998SE |
| K983972 | Immulite Troponin I, Model LKTI1 and LKT15MMI · Traditional | Diagnostic Products Corp. | 12/07/1998SE |
| K981882 | Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid TestMMI · Traditional | Princeton BioMeditech Corp. | 07/06/1998SE |
| K981098 | Stratus CS Cardiac Troponin I TestpakMMI · Traditional | Dade Behring, Inc. | 04/27/1998SE |
| K980528 | Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional | Chiron Diagnostics Corp. | 03/03/1998SE |
| K974839 | Alpha DX Analyzer 01-0100, Alpha DX Myo/Ck/Ck-Mb/Tni Cardiac Panel Test Kit 03-0001…MMI · Traditional | First Medical, Inc. | 02/04/1998SE |
| K974818 | ABL555 Blood Gas, Electrolyte & Metabolite SystemMMI · Traditional | Radiometer America, Inc. | 01/16/1998SE |
| K973616 | Troponin I Assay for the Bayer Immuno 1 SystemMMI · Traditional | Bayer Corp. | 12/05/1997SE |
| K974103 | Abbott Axsym Troponin-IMMI · Traditional | Abbott Laboratories | 11/25/1997SE |
| K974075 | Access Troponin I Reagents on the Access Immunoassay AnalyzerMMI · Traditional | Beckman Instruments, Inc. | 11/10/1997SE |
| K973650 | Troponin (Trop) MethodMMI · Traditional | Dade Chemistry Systems, Inc. | 10/20/1997SE |
| K972094 | Target Cardiac Troponin I TestMMI · Traditional | Texas Immunology, Inc. | 07/23/1997SE |
| K964862 | Troponin-I Test SystemMMI · Traditional | Dade Intl., Inc. | 02/10/1997SE |
| K964372 | Cardiac T Troponin T Rapid AssayMMI · Traditional | Boehringer Mannheim Corp. | 02/10/1997SE |
| K963934 | Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320…MMI · Traditional | Bio-Rad Laboratories, Inc. | 12/16/1996SE |
| K963513 | Cardiac Status Troponin IMMI · Traditional | Princeton BioMeditech Corp. | 11/07/1996SE |
| K961500 | Elecsys Troponin TMMI · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K955868 | Boehringer Mannheim Cardiac T Tropnin TMMI · Traditional | Boehringer Mannheim Corp. | 02/14/1996SE |
| K955284 | Opus Troponin IMMI · Traditional | Behring Diagnostics, Inc. | 01/25/1996SE |
| K952478 | Boehringer Mannheim Cardiac T Troponin T Rapid AssayMMI · Traditional | Boehringer Mannheim Corp. | 11/09/1995SE |
| K951890 | Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac…MMI · Traditional | Dade Intl., Inc. | 07/13/1995SE |
| K924392 | Cardiac T Elisa Troponin-TMMI · Traditional | Boehringer Mannheim Corp. | 04/26/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0727-2025 Class II | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the…Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for… | Beckman Coulter, Inc. | 11/18/2024Open, Classified |
| Z-2358-2023 Class II | VITROS Immunodiagnostic Products Troponin I ES CalibratorsReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially… | Ortho-Clinical Diagnostics | 06/05/2023Open, Classified |
| Z-2357-2023 Class II | VITROS Immunodiagnostic Products Troponin I ES Reagent PackReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially… | Ortho-Clinical Diagnostics | 06/05/2023Open, Classified |
| Z-1974-2023 Class I | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and…Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction… | Quidel Cardiovascular Inc | 05/25/2023Open, Classified |
| Z-1660-2022 Class II | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the… | Abbott Laboratories | 07/26/2022Open, Classified |
| Z-1341-2022 Class II | Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac…Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th… | Siemens Healthcare Diagnostics, Inc. | 05/18/2022Terminated |
| Z-1340-2022 Class II | Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac…Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th… | Siemens Healthcare Diagnostics, Inc. | 05/18/2022Terminated |
| Z-0032-2022 Class II | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT…Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL… | Beckman Coulter Inc. | 08/09/2021Open, 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… | Roche Diagnostics Operations, Inc. | 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… | Roche Diagnostics Operations, Inc. | 04/07/2021Open, Classified |
| Z-0052-2021 Class II | Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro…Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control… | Siemens Healthcare Diagnostics, Inc. | 08/19/2020Terminated |
| Z-2927-2020 Class II | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro…Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples | Siemens Healthcare Diagnostics, Inc. | 07/24/2020Terminated |
| Z-0761-2020 Class II | i-STAT cTnI cartridgei-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed… | Abbott Point Of Care Inc. | 10/16/2019Terminated |
| Z-2135-2019 Class II | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test…Potential for increased rate of false positive results and/or increased rate of random non-repeatable false… | Siemens Healthcare Diagnostics Inc | 05/29/2019Terminated |
| Z-2436-2018 Class II | Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective… | Siemens Healthcare Diagnostics, Inc. | 03/21/2018Terminated |
| Z-2073-2018 Class II | ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1671-2018 Class II | Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-2606-2017 Class II | Dimension Troponin 1 (TNI) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | Siemens Healthcare Diagnostics, Inc. | 03/21/2017Terminated |
| Z-2041-2016 Class II | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative…Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L).… | Siemens Healthcare Diagnostics, Inc | 05/02/2016Terminated |
| Z-0609-2016 Class II | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-2207-2015 Class II | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests…System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc | 05/19/2015Terminated |
| Z-0801-2015 Class II | Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of… | Siemens Healthcare Diagnostics, Inc. | 10/27/2014Terminated |
| Z-1991-2014 Class II | ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708…The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in… | Siemens Healthcare Diagnostics, Inc | 05/30/2014Terminated |
| Z-0716-2013 Class II | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is…APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode… | Abbott Point of Care Canada Limited | 11/01/2012Terminated |
| Z-1509-2012 | ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro…The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to… | Abbott Laboratories | 04/11/2012Terminated |
| 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… | Roche Diagnostics Operations, Inc. | 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… | Roche Diagnostics Operations, Inc. | 03/12/2012Terminated |
| Z-2237-2012 Class II | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic…Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly… | Abbott Point Of Care Inc. | 03/07/2012Terminated |
| Z-1467-2012 | Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis…Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP… | Alere San Diego | 03/05/2012Terminated |
| Z-1466-2012 | Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the…Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP… | Alere San Diego | 03/05/2012Terminated |
| Z-2169-2012 Class II | i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro…The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric… | Abbott Point Of Care Inc. | 02/01/2012Terminated |
| Z-0180-2012 | i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement…i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported… | Abbott Point Of Care Inc. | 09/29/2011Terminated |
| Z-1732-2011 | Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute…Low frequency of non-repeatable falsely elevated CTNI results without an associated error message. | Siemens Healthcare Diagnostics, Inc. | 12/23/2010Terminated |
| Z-2400-2010 | Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)False elevated Stratus CS CTNI results | Siemens Healthcare Diagnostics, Inc. | 04/13/2010Terminated |
| Z-0460-2011 | The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | Siemens Healthcare Diagnostics, Inc. | 04/12/2010Terminated |
| Z-1995-2010 | Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access…The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has… | Beckman Coulter Inc. | 03/11/2010Terminated |
| Z-1318-2010 | Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl…The recall was initiated because Beckman Coulter has confirmed customer reports that different results have… | Beckman Coulter Inc. | 02/06/2010Terminated |
| Z-1883-2011 | Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 The Access…The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following… | Beckman Coulter Inc. | 12/10/2009Terminated |
| Z-1391-2009 | Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in…The recall was initiated because the use of the affected lot may lead to reporting falsely low values for… | Biosite Inc | 04/27/2009Terminated |
| Z-1051-2009 | AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | Abbott Laboratories | 01/19/2009Terminated |
| Z-1555-2009 | Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used…The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit… | Siemens Healthcare Diagnostics, Inc. | 04/28/2008Terminated |
| Z-1731-2009 | Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the…possibility of falsely elevated results | Siemens Healthcare Diagnostics, Inc. | 04/08/2008Terminated |
| Z-1108-2008 | UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access…Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective… | Beckman Coulter Inc | 07/19/2007Terminated |
| Z-0580-2008 | ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog #…Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the… | Siemens Medical Solutions Diagnostics | 06/07/2007Terminated |
| Z-0820-2007 | VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A…Quality control and patient results can be lower than expected when the true Troponin I value is less than… | Ortho-Clinical Diagnostics | 04/27/2007Terminated |
| Z-1023-2007 | AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-0855-2007 | ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100…False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might… | Abbott Laboratories MPG | 03/08/2007Terminated |
| Z-0858-2010 | Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521.…Tests exhibit falsely elevated results. | Siemens Healthcare Diagnostics, Inc. | 03/02/2007Terminated |