Real Time Nucleic Acid Amplification System
FDA product code OOI · Class II (moderate risk) · 21 CFR 862.2570 · Clinical Chemistry
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
14510(k) clearances
0PMA approvals
30recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243922 | RevogeneOOI · Traditional | Meridian Bioscience, Inc. | 03/20/2025SE |
| K222779 | RevogeneOOI · Special | Meridian Bioscience, Inc. | 01/26/2023SE |
| K220480 | RevogeneOOI · Traditional | Meridian Bioscience, Inc. | 07/11/2022SE |
| K170558 | revogeneOOI · Traditional | Genepoc, Inc. | 05/25/2017SE |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay…OOI · Special | Luminex Corporation | 06/30/2016SE |
| K160517 | ARIES SystemOOI · Special | Luminex Corporation | 04/12/2016SE |
| K151917 | ARIES SystemOOI · Traditional | Luminex Corporation | 10/06/2015SE |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep AOOI · Special | Alere Scarborough, Inc. | 07/16/2015SE |
| K140447 | BD Viper LT SystemOOI · Traditional | Becton, Dickinson and Company | 05/20/2014SE |
| K123955 | Quantstudio DX Real-Time PCR InstrumentOOI · Traditional | Life Technologies Corporation | 03/08/2013SE |
| K113319 | Rotor-Gene Q MDXOOI · Traditional | QIAGEN GmbH | 02/06/2012SE |
| K102314 | 3M Integrated Cycler (110V) & (220V)OOI · Traditional | Focus Diagnostics, Inc. | 10/29/2010SE |
| K093383 | Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq…OOI · Traditional | bioMerieux, Inc. | 07/06/2010SE |
| K092705 | Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501OOI · Traditional | Abbott Molecular, Inc. | 05/28/2010SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1665-2025 Class II | The Alinity m System is designed to automate the steps for nucleic acid testing. Model…The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system… | Abbott Molecular, Inc. | 03/20/2025Open, Classified |
| Z-0836-2025 Class II | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in…False-positive MSI-H results generated by the Idylla MSI Test. | Biocartis Nv | 12/10/2024Open, Classified |
| Z-1602-2024 Class II | Alinity m System, Part Number: 08N53-002The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the… | Abbott Molecular, Inc. | 03/20/2024Open, Classified |
| Z-1190-2024 Class III | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number…Products that were intended for export only which were not approved or registered in accordance with U.S.… | Abbott Molecular, Inc. | 02/01/2024Open, Classified |
| Z-0782-2024 Class II | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid…Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. | Hologic, Inc. | 12/15/2023Open, Classified |
| Z-2153-2023 Class II | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification…There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid… | DiaSorin Molecular LLC | 06/14/2023Open, Classified |
| Z-1009-2023 Class II | Alinity m System. The Alinity m System is designed to automate the steps for nucleic…The firm identified the following three potential issues which may have impacted ADUs installed on… | Abbott Molecular, Inc. | 12/09/2022Open, Classified |
| Z-1349-2023 Class II | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification… | Abbott Molecular, Inc. | 11/11/2022Open, Classified |
| Z-0268-2023 Class II | Alinity m System, REF 08N53-002, For In Vitro Diagnostic UseAbbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a… | Abbott Molecular, Inc. | 10/12/2022Open, Classified |
| Z-1479-2022 Class II | Revogene, Catalog no. 610210. IVD test instrumentWhen a run is aborted, the cooling period protection does not occur and the user is able to open the lid… | Meridian Bioscience Inc | 06/22/2022Open, Classified |
| Z-1092-2022 Class II | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene systemHeater within the Verigene System may be outside of established temperature limits for assays which could… | Luminex Corporation | 04/05/2022Open, Classified |
| Z-0836-2022 Class II | Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical…The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is… | Meridian Bioscience Inc | 02/15/2022Open, Classified |
| Z-0710-2022 Class II | Alinity m Integrated Reaction Units (IRU)There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor… | Abbott Molecular, Inc. | 02/11/2022Terminated |
| Z-0457-2022 Class II | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19… | DiaSorin Molecular LLC | 11/19/2021Open, Classified |
| Z-0553-2022 Class II | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes… | Luminex Corporation | 11/17/2021Terminated |
| Z-0828-2022 Class II | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number…Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels… | Roche Molecular Systems, Inc. | 11/16/2021Open, Classified |
| Z-0498-2022 Class II | ARIES HSV 1&2 Assay, Part Number/REF 50-10017Impacted lot may leak inside the ARIES instrument. | Luminex Corporation | 04/16/2021Terminated |
| Z-1476-2020 Class II | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid…When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the… | Qiagen Sciences LLC | 01/28/2020Terminated |
| Z-2288-2019 Class II | ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | Luminex Corporation | 02/20/2019Open, Classified |
| Z-2292-2019 Class II | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic…An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in… | Luminex Corporation | 06/29/2018Terminated |
| Z-2094-2017 Class II | ARIES System and ARIES M1 SystemThe hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen… | Luminex Corporation | 04/19/2017Terminated |
| Z-1866-2017 Class II | BD Viper LT software, version 3.00HBD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems… | Bd Diagnostic | 12/14/2015Terminated |
| Z-1816-2015 Class II | BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec…Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when… | Becton Dickinson & Co. | 11/07/2014Terminated |
| Z-1111-2014 Class II | cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media…Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from… | Roche Molecular Systems, Inc. | 01/06/2014Terminated |
| Z-1346-2013 Class II | cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid…In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the… | Roche Molecular Systems, Inc. | 04/01/2013Terminated |
| 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… | Roche Diagnostics Operations, Inc. | 03/01/2013Terminated |
| Z-2159-2012 Class III | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas…During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was… | Roche Molecular Systems, Inc. | 02/24/2012Terminated |
| Z-0048-2012 | Abbott m2000rt System software; an automated system for performing fluorescence-based…The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test… | Abbott Molecular | 09/08/2011Terminated |
| Z-2740-2011 | NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic…The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples. | bioMerieux, Inc. | 05/10/2011Terminated |
| 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… | Roche Diagnostics Operations, Inc. | 10/26/2010Terminated |