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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 30 of 92 Results
Product: pcr
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PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF ... 2 03/29/2023 Entopsis , Inc.
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 783781... 2 03/29/2023 Entopsis , Inc.
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the ... 2 03/29/2023 Entopsis , Inc.
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SA... 2 01/20/2023 Meridian Bioscience Inc
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
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