Rapid Response
BTNX Inc · Model D9.11-1V · UDI-DI 00722066004678
1
510(k) clearances
0
Adverse events
1
Recalls
52
Facilities
Description
One Step 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
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.