FDA Device recall Z-1412-2021
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
- FDA Device
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit by Fujifilm Medical Systems U, citing potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1412-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-18 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | CA, LA, MN, NC, UT, WI |
Product
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Reason
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Identifiers
| code_info | Lot Number: EQ194 Exp. Date: 05/31/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Fujifilm Medical Systems U recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1412-2021%22
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