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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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Zyston® Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
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2
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08/11/2016
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Zimmer Biomet Spine, Inc
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Zyston® Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
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2
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08/11/2016
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Zimmer Biomet Spine, Inc
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Xpert EV Assay, Catalog GXEV-100N-10.
The Cepheid Xpert EV assay is a reverse transcription polym...
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2
|
10/18/2017
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Cepheid
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Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/...
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2
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02/12/2018
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Cepheid
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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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Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204
...
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2
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01/14/2015
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Biomet Spine, LLC
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The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi...
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2
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01/12/2021
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Roche Molecular Systems, Inc.
|
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The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta...
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2
|
09/23/2014
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Nanosphere, Inc.
|
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The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di...
|
2
|
09/23/2014
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Nanosphere, Inc.
|
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The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2...
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2
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09/17/2020
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Life Technologies Corporation
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