Fujifilm Medical Systems U.S.A., Inc. Recall 87507
Description: ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Fujifilm Medical Systems U.S.A., Inc. Recall 87507 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1412-2021 |
| Event ID | 87507 |
| Event Description | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit |
| Product Type | Devices |
| Distribution | CA, LA, MN, NC, UT, WI |
| Quantity | 496 units |
| Recall Reason | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result |
| Device Classification | 20210421 |
| Device Code Info | Lot Number: EQ194 Exp. Date: 05/31/2022 |
| Center Classification Date | 20210412 |
| Recall Initiation Date | 20210218 |
| Recalling Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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