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IMMAGE
Beckman Coulter, Inc. · Model 447760 · UDI-DI 15099590224073
JZH
Prescription
6
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities
Description
IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-10-16 | Diagnostic Hybrids Inc | Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented. |
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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.