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U.S. Department of Health and Human Services

Medical Device Recalls
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41 to 50 of 96 Results
Product: pcr
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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.
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 ... 2 09/15/2021 Quidel Corporation
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolati... 2 12/18/2013 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.
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 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN M... 2 03/14/2011 Roche Diagnostics Operations, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen... 3 08/08/2014 Nanosphere, Inc.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo... 3 02/01/2021 Biomeme, Inc.
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 2 08/17/2021 OPTI Medical Systems, 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
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