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IMMULITE®/IMMULITE®1000 Systems AF AFP
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10381162 · UDI-DI 00630414963594
0
510(k) clearances
160
Adverse events
1
Recalls
10
Facilities
Description
AF AFP Kit 100 Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-06-12 | Abbott Laboratories HPD/ADD | AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5% |
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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.