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U.S. Department of Health and Human Services

Medical Device Recalls
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31 to 40 of 98 Results
Product: pcr
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cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) ... 2 10/17/2022 Roche Molecular Systems, Inc.
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 2 08/29/2022 Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 2 08/29/2022 Qiagen Sciences LLC
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 2 08/29/2022 Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) 2 04/19/2022 Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) 2 04/19/2022 Qiagen Sciences LLC
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A S... 2 03/01/2022 Microbiologics Inc
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent... 2 01/04/2022 Biomeme, Inc.
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
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