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U.S. Department of Health and Human Services

Medical Device Recalls

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41 to 50 of 92 Results
Product: pcr
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cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Produc... 2 10/25/2016 Roche Diagnostics Operations, Inc.
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040... 2 08/29/2016 Philips Electronics North America Corporation
Zyston® Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. 2 08/11/2016 Zimmer Biomet Spine, Inc
Zyston® Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. 2 08/11/2016 Zimmer Biomet Spine, Inc
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 ... 2 07/21/2016 Roche Molecular Systems, Inc.
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 ... 2 01/14/2015 Biomet Spine, LLC
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage:... 2 12/16/2014 Biomet Spine LLC.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di... 2 09/23/2014 Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta... 2 09/23/2014 Nanosphere, Inc.
cobas® PCR Urine Kit 100 PKT IVD cobas® PCR Female Swab Kit 100 PKT IVD cobas® PCR media 100T IVD ... 2 02/26/2014 Roche Molecular Systems, Inc.
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