Z-1412-2021 Class II Terminated
FDA device recall Z-1412-2021 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Feb 18, 2021 and is designated Class II. Reason for recall: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result The recall status is terminated (terminated Feb 24, 2022). Affected quantity: 496 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 21, 2021
- Initiation Date
- Feb 18, 2021
- Termination Date
- Feb 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496 units
Product Description
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Reason for Recall
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Distribution Pattern
CA, LA, MN, NC, UT, WI
Code Information
Lot Number: EQ194 Exp. Date: 05/31/2022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1412-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026