RecallDepth

TASWako Chip Cassette is part of the Wako TASWako i30 kit

Company
Fujifilm Medical Systems U.S.A., Inc.
Recall Initiated
February 18, 2021
Terminated
February 24, 2022
Recall Number
Z-1412-2021
Quantity
496 units
Firm Location
Lexington, MA

Reason for Recall

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

Distribution

CA, LA, MN, NC, UT, WI

Lot / Code Info

Lot Number: EQ194 Exp. Date: 05/31/2022

Root Cause

Under Investigation by firm

Action Taken

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.

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