Quidel Corporation - Sofia 2 Flu SARS Antigen FIA - Class 2 Recall
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2024 Category: Medical Devices Source Type: alerts
Universal Meditech Inc. - DiagnosUS SARSCoV2 Antibody (IgG/IgM) Test - Class 2 Recall
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 24, 2023 Category: Medical Devices Source Type: alerts
Qiagen GmbH - QIAstatDx Respiratory SARSCoV2 Panel - Class 2 Recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2023 Category: Medical Devices Source Type: alerts
Qiagen GmbH - QIAstatDx Respiratory SARSCoV2 Panel - Class 2 Recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2023 Category: Medical Devices Source Type: alerts
Qiagen GmbH - QIAGEN QIAstatDx - Class 2 Recall
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
NeuMoDx Molecular Inc - NeuMoDx SARSCoV2 Assay - Class 3 Recall
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2023 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BD Veritor System for Rapid Detection of SARSCoV2 & Flu AB - Class 2 Recall
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
Qiagen Sciences LLC - QIAstatDx Respiratory SARSCoV2 Panel - Class 2 Recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - cobas SARSCoV2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems - Class 2 Recall
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2023 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - cobas SARSCoV2 & Influenza A/B assay for use on the cobas 5800/6800/8800 Systems - Class 2 Recall
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2023 Category: Medical Devices Source Type: alerts
Universal Meditech Inc. - COVID19 Rapid Antigen Tests - Class 1 Recall
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Meridian Bioscience Inc - Meridan - Class 2 Recall
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2023 Category: Medical Devices Source Type: alerts
LumiraDx - Class 3 Recall
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2022 Category: Medical Devices Source Type: alerts
Luminex Corporation - Luminex' ARIES SARSCoV2 Assay - Class 2 Recall
ARIES SARS-CoV-2 Assay, REF: 50-10047 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite Inactivated Standard - Class 3 Recall
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2022 Category: Medical Devices Source Type: alerts
