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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for ...
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2
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01/10/2024
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BioFire Diagnostics, LLC
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XScribe Cardiac Stress Testing System, version 6, with below product names and codes:
a) XS6/RS6 REV...
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2
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01/10/2024
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Baxter Healthcare Corporation
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Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes:
a) QS6 A...
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2
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01/10/2024
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Baxter Healthcare Corporation
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Procedure packs:
(1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile;
(2) Presource PBDS Cat. POC...
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2
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10/10/2023
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Cardinal Health 200, LLC
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therascreen ®KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument...
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2
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09/29/2023
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Qiagen GmbH
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QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Numbe...
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2
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06/02/2023
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Qiagen Sciences LLC
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PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a varie...
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 5978...
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2
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03/29/2023
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Entopsis , Inc.
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PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF ...
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2
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03/29/2023
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Entopsis , Inc.
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