Rapid Response
BTNX Inc · Model D12.5.1-1VA · UDI-DI 10722066005672
1
510(k) clearances
0
Adverse events
1
Recalls
50
Facilities
Description
One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 pH/CRE/SG.
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.