Rapid Response
BTNX Inc · Model D5.75-1V · UDI-DI 00722066005095
1
510(k) clearances
0
Adverse events
1
Recalls
52
Facilities
Description
One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-30 | Ameditech Inc | Product was released to market without the adulteration strip included in the product. |
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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.