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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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BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngea...
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2
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06/05/2024
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Becton Dickinson & Co.
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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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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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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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Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay i...
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2
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11/29/2023
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Abbott Molecular, Inc.
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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 Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium...
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2
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03/29/2023
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Entopsis , Inc.
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