FDA-Device2021-04-21Class II
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Sold states
CA, LA, MN, NC, UT, WI
Affected count
496 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2021Don't want to check this manually?
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