¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit — Class II medical device recall Z-1412-2021
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-04-21, distributed in CA, LA, MN, NC, UT, WI. Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3%
| Recall number | Z-1412-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Lexington, MA, United States |
| Recall initiated | 2021-02-18 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-02-24 |
| Distributed | CA, LA, MN, NC, UT, WI |
| Quantity | 496 units |
| Lot numbers | EQ194 |
| Expiration dates | 2022-05-31 |
Product
¿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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1412-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.