Fujifilm Medical Systems U.S.A., Inc. recalls ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
- Recall date
- February 18, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1412-2021
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- CA, LA, MN, NC, UT, WI
Why it was recalled
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
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