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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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FDA Recall
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Neoprobe GDS Control Unit, Model Number NPCU3 3 10/08/2020 FEI # 3008492462
Devicor Medical Products Inc
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage:... 3 09/23/2020 FEI # 3004142665
OraSure Technologies, Inc.
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for o... 3 09/23/2020 FEI # 3004142665
OraSure Technologies, Inc.
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-cou... 3 09/23/2020 FEI # 3004142665
OraSure Technologies, Inc.
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96)... 3 09/23/2020 FEI # 3003742580
DNA Genotek Inc.
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as ... 3 09/16/2020 FEI # 3006017427
Oxford Immunotec
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as ... 3 09/16/2020 FEI # 3006017427
Oxford Immunotec
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Ce... 3 09/12/2020 FEI # 3008355164
Maquet Cardiovascular Us Sales, Llc
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coat... 3 08/24/2020 FEI # 3004142665
OraSure Technologies, Inc.
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coate... 3 08/24/2020 FEI # 3004142665
OraSure Technologies, Inc.

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