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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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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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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 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 Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the ...
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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-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 783781...
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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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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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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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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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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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