Beckman Coulter Inc. - ACCESS SARSCoV2 Antigen - Class 2 Recall
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - ACCESS SARSCoV2 ANTIGEN QC - Class 2 Recall
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737; (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
Quidel Corporation - Lyra SARSCoV2 Assay (M120) - Class 1 Recall
Lyra SARS-CoV-2 Assay (M120) (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Access SARS Cov2 lgG II Reagent - Class 2 Recall
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Access SARS CoV2 lgG II Calibrator - Class 2 Recall
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2021 Category: Medical Devices Source Type: alerts
INNOVA MEDICAL GROUP, INC. - INNOVA SARSCoV2 Antigen Rapid Qualitative Test - Class 1 Recall
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2021 Category: Medical Devices Source Type: alerts
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD - The SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) - Class 1 Recall
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2021 Category: Medical Devices Source Type: alerts
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD - Leccurate SARSCoV2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) - Class 1 Recall
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, INc. - VITROS Immunodiagnostic Products SARSCoV2 Antigen Calibrator. - Class 2 Recall
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDC s formulation of VTM. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 28, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - SARS CoV2 Antigen - Class 2 Recall
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2021 Category: Medical Devices Source Type: alerts
Meridian Bioscience Inc - Meridian Revogene SARSCoV2 Software Upgrade Kit - Class 2 Recall
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2021 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - Class 2 Recall
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2021 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BioGX SARSCoV2 Reagents for BD MAX System (REF 444213) - Class 2 Recall
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2021 Category: Medical Devices Source Type: alerts
LumiraDx - LumiraDx Instrument - Class 2 Recall
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, Inc. - Ortho Clinical Diagnistics VITROS Immunodiagnostic Products SARSCoV2 Antigen Reagent Pack - Class 2 Recall
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. . For emergency authorization use only (EAU). Intended for Use in the United States Product Code: 6199949. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
