Abbott Molecular, Inc. - Alinity m SARSCoV2 Amp Kit Assay - Class 1 Recall
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - ACCESS SARS CoV2 IgG (1st IS) Assay - Class 2 Recall
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2021 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - cobas SARSCoV2 & Influenza A/B Test - Class 2 Recall
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts
Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Pellet) - Class 2 Recall
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts
Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Swab) - Class 2 Recall
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts
Quidel Corporation - Class 2 Recall
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - FaStep COVID19 IgG/IgM Rapid Test Device - Class 2 Recall
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Status COVID19/Flu Rapid Immunoassay - Class 2 Recall
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Healgen COVID19 IgG/IgM Rapid Test Cassette - Class 2 Recall
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity te...
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - CareStart COVID19 Antigen Rapid Diagnostic Test - Class 2 Recall
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Thera Test Laboratories, Inc. - ELAntiSARSCoV2 IgG Kit - Class 2 Recall
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2021 Category: Medical Devices Source Type: alerts
Thera Test Laboratories, Inc. - ELAntiSARSCoV2 IgM Kit - Class 2 Recall
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2021 Category: Medical Devices Source Type: alerts
OPTI Medical Systems, Inc - OPTI SARSCoV2 RTPCR Test - Class 2 Recall
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - ACCESS SARSCoV2 ANTIGEN EXTRACTION SOLUTION - Class 2 Recall
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Access SARSCoV2 Antigen Calibrators - Class 2 Recall
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720; (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
