Rapid Response
BTNX Inc · Model ROT-9C20 · UDI-DI 00722066001899
LIQ
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
14
Facilities
Description
Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-25 | MEDLINE INDUSTRIES, LP - Northfield | The product was incorrectly shipped at room temperature rather than refrigerated. |
| 2021-12-01 | MEDLINE INDUSTRIES, LP - Northfield | Product stored incorrectly in temperature controlled setting instead of refrigeration. |
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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.