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Hemoglobin G6PDH Normal Control
ANALYTICAL CONTROL SYSTEMS INC · Model HC-108 · UDI-DI 00817869020137
1
510(k) clearances
5
Adverse events
1
Recalls
9
Facilities
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.