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U.S. Department of Health and Human Services

Medical Device Recalls
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Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo... 3 02/01/2021 FEI # 3014117298
Biomeme, Inc.
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LD... 3 01/28/2021 FEI # 1000513161
Fujifilm Medical Systems U.S.A., Inc.
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Bo... 3 12/23/2020 FEI # 1526012
Applied Medical Technology Inc
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication... 3 12/01/2020 FEI # 2023129
Talladium Inc
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the followi... 3 11/25/2020 FEI # 1000220815
Advanced Bionics, LLC
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the followi... 3 11/25/2020 FEI # 1000220815
Advanced Bionics, LLC
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry ... 3 11/18/2020 FEI # 2250051
Ortho Clinical Diagnostics Inc
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to ass... 3 11/16/2020 FEI # 1527821
Steris Corporation
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 3 11/10/2020 FEI # 2022807
Hardy Diagnostics
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, ... 3 11/06/2020 FEI # 3005031160
XTANT Medical

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