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GENCHEM™ Albumin Reagent
GENCHEM INC · Model GEN-ALB · UDI-DI 00851445007006
CJW
Prescription
10
510(k) clearances
17
Adverse events
1
Recalls
24
Facilities
Description
10/17/2022
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-18 | Roche Diagnostics Corporation | The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. |
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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.