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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 23 of 23 Results
Product: sars Recall Date from: 01/01/2021 Recall Date to: 07/26/2021
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Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent 1 06/26/2021 Quidel Corporation
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 2 06/21/2021 Beckman Coulter Inc.
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 2 06/21/2021 Beckman Coulter Inc.
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualita... 1 06/10/2021 INNOVA MEDICAL GROUP, INC.
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. fo... 1 05/28/2021 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. ... 1 05/28/2021 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay... 2 05/27/2021 Ortho-Clinical Diagnostics, INc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1... 2 05/21/2021 Beckman Coulter Inc.
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C... 2 05/07/2021 Meridian Bioscience Inc
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for... 2 04/13/2021 Roche Molecular Systems, 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.
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of... 2 03/26/2021 LumiraDx
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunod... 2 03/17/2021 Ortho-Clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Rea... 2 03/17/2021 Ortho-Clinical Diagnostics, Inc.
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syn... 2 02/17/2021 LumiraDx
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVI... 2 02/16/2021 Sky Medical Supplies and Equipments LLC
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Prod... 2 02/16/2021 Confirm Biosciences Inc
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usa... 2 02/16/2021 Confirm Biosciences Inc
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. ... 2 02/05/2021 Becton Dickinson & Co.
SARS-CoV-2 Antigen Test 2 02/01/2021 Qiagen Sciences LLC
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immu... 2 01/15/2021 Beckman Coulter Inc.
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV... 2 01/12/2021 VISBY MEDICAL INC
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, I... 2 01/11/2021 Ansh Labs, LLC
 
 
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