Medical device recalls Moderate risk

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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