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CorDx Tyfast
CORETESTS, INC. · Model ACT21001-25 · UDI-DI 00850042559635
QMN
Prescription
0
510(k) clearances
3,840
Adverse events
7
Recalls
25
Facilities
Description
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-03 | Quidel Corporation | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 3 |
| 2023-10-25 | PHASE SCIENTIFIC INTERNATIONAL LIMITED | COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could pr |
| 2023-05-01 | Becton Dickinson & Co. | IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing |
| 2021-07-27 | Versea Diagnostics LLC | Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorizat |
| 2020-11-05 | VEO DIAGNOSTICS, LLC | Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests |
| 2020-09-30 | Ortho Clinical Diagnostics Inc | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot |
| 2020-09-30 | Ortho Clinical Diagnostics Inc | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.