Fujifilm Medical Systems U.S.A., Inc. TASWako Chip Cassette is part of the Wako TASWako i30 kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TASWako Chip Cassette is part of the Wako TASWako i30 kit
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Lot Number: EQ194 Exp. Date: 05/31/2022
Products Sold
Lot Number: EQ194 Exp. Date: 05/31/2022
Fujifilm Medical Systems U.S.A., Inc. is recalling TASWako Chip Cassette is part of the Wako TASWako i30 kit due to Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Recommended Action
Per FDA guidance
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 chip cassette boxes (each containing 5 x 20 chips) from a different lot. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, LA, MN, NC, UT, WI
Page updated: Jan 10, 2026