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U.S. Department of Health and Human Services

Medical Device Recalls
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31 to 40 of 92 Results
Product: pcr
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Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A S... 2 03/01/2022 Microbiologics Inc
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent... 2 01/04/2022 Biomeme, Inc.
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 ... 2 09/15/2021 Quidel Corporation
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 2 08/17/2021 OPTI Medical Systems, Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C... 2 05/07/2021 Meridian Bioscience Inc
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of ... 2 04/13/2021 Becton Dickinson & Co.
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancil... 2 04/07/2021 Hologic, Inc
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. ... 2 02/05/2021 Becton Dickinson & Co.
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati... 2 01/29/2021 Qiagen Sciences LLC
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.
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