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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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therascreen ®KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument... 2 09/29/2023 Qiagen GmbH
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati... 2 01/29/2021 Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) 2 04/19/2022 Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) 2 04/19/2022 Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 2 08/29/2022 Qiagen Sciences LLC
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 2 06/05/2020 Qiagen Sciences LLC
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.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Produc... 2 10/25/2016 Roche Diagnostics Operations, Inc.
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 ... 2 07/21/2016 Roche Molecular Systems, Inc.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) ... 2 10/17/2022 Roche Molecular Systems, Inc.
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