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Co-Innovation Biotech Co., Ltd · Model ETG-Dipcard · UDI-DI 06970429840638
DJZ
Prescription
10
510(k) clearances
12
Adverse events (1 deaths)
3
Recalls
42
Facilities
Description
Rapid ETG Test Dipcard
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-17 | Acon Laboratories, Inc. | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. |
| 2007-11-30 | Sakar International, Inc. | Marketed without a 510(k) |
| 2005-11-30 | WNCK, Inc | Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff. |
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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.