Battelle Memorial Institute - Battelle Critical Care Decontamination System (CCDS) - Class 2 Recall
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 30, 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
Precision Valve & Automation,Inc - PVA, PREVENT - Class 2 Recall
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 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
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
