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U.S. Department of Health and Human Services

Medical Device Recalls
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Choleodochoscope- Models: CHF-BP30 CHF-CB30L CHF-P60 3 11/17/2023 Aizu Olympus Co., Ltd.
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing 3 09/11/2023 Microbiologics Inc
ZVU Functional GI Software, REF: ZVU-3 3 09/07/2023 Diversatek Healthcare
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For ... 3 07/21/2023 Ortho-Clinical Diagnostics, Inc.
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, ... 3 07/05/2023 NeuMoDx Molecular Inc
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material t... 3 06/28/2023 Randox Laboratories Ltd.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor ... 3 06/28/2023 Randox Laboratories Ltd.
Total Knee Pack, REF CETJ130, medical convenience kits 3 06/15/2023 American Contract Systems, Inc.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-... 3 06/14/2023 Datascope Corp.
Alinity i Anti-TPO Reagent Kit, List Number 09P3521 3 06/08/2023 Abbott Ireland Limited

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