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Trinity Biotech
CLARK LABORATORIES, INC. · Model G5029 · UDI-DI 05391516743136
1
510(k) clearances
5
Adverse events
1
Recalls
9
Facilities
Description
G6PDH Control, Intermediate
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-12-09 | Roche Diagnostics Corp. | Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2. |
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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.