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Fujifilm Medical Systems U.S.A., Inc. recalls ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Recalled April 21, 2021 · FDA recall Z-1412-2021 · Fujifilm Medical Systems U.S.A
Hazard
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result · FDA Class II
Units
496 units
Sold at
CA, LA, MN, NC, UT, WI
Description
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Product
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →