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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 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 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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PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Ph...
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2
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02/04/2011
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Philips Medical Systems North America Co. Phillips
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PCR Eleva Radiological Image Processing System with software R.1.2
Philips Healthcare, Inc.
A c...
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2
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09/14/2011
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Philips Healthcare Inc.
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PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040...
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2
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08/29/2016
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Philips Electronics North America Corporation
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OPTI SARS-CoV-2 RT-PCR Test, REF Numbers:
a) 99-57003
b) 99-57004
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2
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08/17/2021
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OPTI Medical Systems, Inc
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Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo...
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3
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02/01/2021
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Biomeme, Inc.
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Nanosphere Verigene
Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen...
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3
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08/08/2014
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Nanosphere, Inc.
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