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uTASWako AFP-L3
FUJIFILM WAKO PURE CHEMICAL CORPORATION · Model 999-60601 · UDI-DI 00856626006205
NSF
Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
7
Facilities
Description
In-Vitro Diagnostic Use
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-18 | Fujifilm Medical Systems U.S.A., Inc. | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result |
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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.