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DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit
Nuclein, LLC · Model SG-0008 · UDI-DI 00850063063029
PMN
Prescription
1
510(k) clearances
1
Adverse events
4
Recalls
10
Facilities
Description
DASH® SARS-CoV-2 & Flu A/B Positive Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-16 | Microbiologics Inc | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-01-31 | Microbiologics Inc | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. |
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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.