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IMMAGE
Beckman Coulter, Inc. · Model 447710 · UDI-DI 15099590180140
MGA
Prescription
2
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities
Description
IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-17 | Kamiya Biomedical Company, LLC | Standardization of the reagent performance data did not match the standardization used to assign the calibrator 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.
