Recall Z-1412-2021 ยท NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Fujifilm Medical Systems U.S.A., Inc.
TASWako Chip Cassette is part of the Wako TASWako i30 kit
| Date | Feb 18, 2021 |
| Status | Terminated |
| Reason | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result |
| Root cause | Under Investigation by firm |
| Action | Fujifilm issued Consignee notifications via courier delivery and electronic mail on February 18, 2021. The letter states reason for recall, health risk and action to take: FUJIFILM is recommending that you immediately cease use of any Cavity #2 chips in Lot EQ194 and return the product to FUJIFILM. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken: Upon receipt of the Field Action Verification Form, FUJIFILM will provide replacement |
| Quantity | 496 units |
| Distribution | CA, LA, MN, NC, UT, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION Wako Chemicals USA, Inc., Feb 23, 2011 |