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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 92 Results
Product: pcr
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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
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 A... 2 01/10/2024 Baxter Healthcare Corporation
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REV... 2 01/10/2024 Baxter Healthcare Corporation
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 BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples 2 03/29/2023 Entopsis , Inc.
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium... 2 03/29/2023 Entopsis , Inc.
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a varie... 2 03/29/2023 Entopsis , Inc.
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 5978... 2 03/29/2023 Entopsis , Inc.
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