Home › Alere Scarborough, Inc. › ID NOW COVID-19 2.0
ID NOW COVID-19 2.0
Alere Scarborough, Inc. · Model 192-000 · UDI-DI 00811877011354
QWR
Prescription
1
510(k) clearances
161
Adverse events
2
Recalls
5
Facilities
Description
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.