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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

DateFirmReason
2008-09-17Kamiya Biomedical Company, LLCStandardization of the reagent performance data did not match the standardization used to assign the calibrator values.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.