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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: pcr
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cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) ... 2 10/17/2022 Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi... 2 01/12/2021 Roche Molecular Systems, Inc.
LightMix® Zika rRT-PCR Test The LightMix® Zika rRT-PCR Test is a real-time RT-PCR test intended for... 2 12/13/2016 Roche Molecular Systems, Inc.
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 ... 2 07/21/2016 Roche Molecular Systems, 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.
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway ... 2 09/10/2013 Roche Molecular Systems, Inc.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quant... 2 12/07/2012 Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with ... 2 12/07/2012 Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection a... 2 12/07/2012 Roche Molecular Systems, Inc.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutat... 3 08/08/2012 Roche Molecular Systems, Inc.
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