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Recall Observatory FDA recall evidence

Device product

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

Z-1412-2021

February 18, 2021

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 87507
Status
Terminated
Classification
Class II
Quantity
496 units
Official record key
device-enforcement:Z-1412-2021

Official wording

Reason: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

Code information: Lot Number: EQ194 Exp. Date: 05/31/2022

Distribution pattern: CA, LA, MN, NC, UT, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

Field note

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