Quidel Corporation - Sofia SARS Antigen Fluorescent Immunoassay (FIA) - Class 2 Recall
QUIDEL Sofia SARS Antigen FIA IVD REF 20374 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2020 Category: Medical Devices Source Type: alerts
Quidel Corporation - Sofia SARS Antigen FIA - Class 2 Recall
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 20, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - TaqPath RTPCR COVID19 Kit with COVID19 Interpretive Software - Class 2 Recall
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - The TaqPath RTPCR COVID19 Kit with Applied Biosystem's COVID19 Interpretive Software - Class 2 Recall
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2020 Category: Medical Devices Source Type: alerts
Qiagen Sciences LLC - QIAstatDx Respiratory SARSCoV2 Panel - Class 2 Recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2020 Category: Medical Devices Source Type: alerts
Chembio Diagnostics, Inc - Chembio DPP COVID19 IgM/IgG System - Class 2 Recall
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2020 Category: Medical Devices Source Type: alerts
Chembio Diagnostics, Inc - The DPP Micro Reader II - Class 2 Recall
Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2020 Category: Medical Devices Source Type: alerts
Chembio Diagnostics, Inc - The DPP Micro Reader - Class 2 Recall
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1069-0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2020 Category: Medical Devices Source Type: alerts
Ortho Clinical Diagnostics - VITROS AntiSARSCoV2 Total Reagent - Class 2 Recall
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2020 Category: Medical Devices Source Type: alerts
Ortho Clinical Diagnostics - VITROS AntiSARSCoV2 IgG Reagent Pack - Class 2 Recall
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2020 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BD MAX SARSCoV2 Reagents - Class 2 Recall
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 5, 2020 Category: Medical Devices Source Type: alerts
