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U.S. Department of Health and Human Services

Medical Device Recalls

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Product: pcr
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Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 ... 2 09/15/2021 Quidel Corporation
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 2 08/17/2021 OPTI Medical Systems, Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C... 2 05/07/2021 Meridian Bioscience Inc
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of ... 2 04/13/2021 Becton Dickinson & Co.
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancil... 2 04/07/2021 Hologic, Inc
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. ... 2 02/05/2021 Becton Dickinson & Co.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo... 3 02/01/2021 Biomeme, Inc.
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati... 2 01/29/2021 Qiagen Sciences LLC
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi... 2 01/12/2021 Roche Molecular Systems, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based o... 2 12/01/2020 Biomeme, Inc.
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 750... 2 09/17/2020 Life Technologies Corporation
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2... 2 09/17/2020 Life Technologies Corporation
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 2 06/05/2020 Qiagen Sciences LLC
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycli... 2 03/12/2020 Qiagen Sciences LLC
Kit BD Max GC RT PCR Assay; Catalog # 443486 2 08/22/2019 Becton Dickinson & Co.
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purp... 2 03/23/2019 LW Scientific, Inc.
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/... 2 02/12/2018 Cepheid
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polym... 2 10/18/2017 Cepheid
LightMix® Zika rRT-PCR Test The LightMix® Zika rRT-PCR Test is a real-time RT-PCR test intended for... 2 12/13/2016 Roche Molecular Systems, Inc.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Produc... 2 10/25/2016 Roche Diagnostics Operations, Inc.
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040... 2 08/29/2016 Philips Electronics North America Corporation
Zyston® Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. 2 08/11/2016 Zimmer Biomet Spine, Inc
Zyston® Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. 2 08/11/2016 Zimmer Biomet Spine, Inc
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 ... 2 07/21/2016 Roche Molecular Systems, Inc.
CytoScan® Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a mic... 3 06/03/2016 Affymetrix Inc
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 ... 2 01/14/2015 Biomet Spine, LLC
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage:... 2 12/16/2014 Biomet Spine LLC.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di... 2 09/23/2014 Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta... 2 09/23/2014 Nanosphere, Inc.
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocyc... 3 09/15/2014 Biofire Defense
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen... 3 08/08/2014 Nanosphere, Inc.
cobas® PCR Urine Kit 100 PKT IVD cobas® PCR Female Swab Kit 100 PKT IVD cobas® PCR media 100T IVD ... 2 02/26/2014 Roche Molecular Systems, Inc.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; label... 2 01/17/2014 Becton Dickinson & Co.
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolati... 2 12/18/2013 Roche Diagnostics Operations, Inc.
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway ... 2 09/10/2013 Roche Molecular Systems, Inc.
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR A... 2 05/14/2013 QIAGEN Gaithersburg, Inc.
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for u... 2 05/14/2013 QIAGEN Gaithersburg, Inc.
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges... 2 03/22/2013 Becton Dickinson & Co.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quant... 2 12/07/2012 Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection a... 2 12/07/2012 Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with ... 2 12/07/2012 Roche Molecular Systems, Inc.
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913... 2 10/31/2012 Wright Medical Technology Inc
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 b... 2 09/06/2012 Becton Dickinson & Co.
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, In... 2 09/06/2012 Becton Dickinson & Co.
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences C... 2 09/06/2012 Becton Dickinson & Co.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutat... 3 08/08/2012 Roche Molecular Systems, Inc.
Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that resul... 2 10/14/2011 Abbott Molecular
PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A c... 2 09/14/2011 Philips Healthcare Inc.
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An aut... 2 08/29/2011 Roche Diagnostics Operations, Inc.
MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated ins... 2 08/29/2011 Roche Diagnostics Operations, Inc.
Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molec... 2 06/14/2011 Roche Molecular Systems, Inc.
Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, In... 2 06/14/2011 Roche Molecular Systems, Inc.
Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis,... 2 03/14/2011 Roche Diagnostics Operations, Inc.
Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor ... 2 03/14/2011 Roche Diagnostics Operations, Inc.
MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN M... 2 03/14/2011 Roche Diagnostics Operations, Inc.
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60... 3 02/23/2011 Abbott Molecular
PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Ph... 2 02/04/2011 Philips Medical Systems North America Co. Phillips
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated a... 3 05/25/2010 Cepheid
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as a... 3 05/25/2010 Cepheid
BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test fo... 2 10/31/2008 BD Diagnostics (GeneOhm Sciences, Inc)
BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test ... 2 10/31/2008 BD Diagnostics (GeneOhm Sciences, Inc)
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V... 2 09/16/2008 Philips Medical Systems North America Co. Phillips
Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument... 2 08/05/2006 Roche Diagnostics Corp.
Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690... 2 08/05/2006 Roche Diagnostics Corp.
Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrume... 2 08/05/2006 Roche Diagnostics Corp.
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification... 2 04/19/2006 Roche Diagnostics Corp.
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler 2 08/17/2005 Cepheid
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutio... 2 09/23/2003 International Surgical Supply, Inc.
 
 
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