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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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BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngea... 2 06/05/2024 Becton Dickinson & Co.
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for ... 2 01/10/2024 BioFire Diagnostics, LLC
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REV... 2 01/10/2024 Baxter Healthcare Corporation
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 A... 2 01/10/2024 Baxter Healthcare Corporation
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay i... 2 11/29/2023 Abbott Molecular, Inc.
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POC... 2 10/10/2023 Cardinal Health 200, LLC
therascreen ®KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument... 2 09/29/2023 Qiagen GmbH
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Numbe... 2 06/02/2023 Qiagen Sciences LLC
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.
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