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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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cobas p 512 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Produc...
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2
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10/25/2016
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Roche Diagnostics Operations, 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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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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cobas EGFR Mutation Test V2
Materials number
CE-IVD: EGFR v2: 07248563190
cfDNA: 07247737190
...
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2
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07/21/2016
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Roche Molecular Systems, Inc.
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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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LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.
Product Usage:...
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2
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12/16/2014
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Biomet Spine LLC.
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The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di...
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2
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09/23/2014
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Nanosphere, 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
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09/23/2014
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Nanosphere, Inc.
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cobas® PCR Urine Kit 100 PKT IVD
cobas® PCR Female Swab Kit 100 PKT IVD
cobas® PCR media 100T IVD
...
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2
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02/26/2014
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Roche Molecular Systems, Inc.
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