Terminated

TASWako Chip Cassette is part of the Wako TASWako i30 kit

FDA Recall Z-1412-2021 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.

Recall StatusTerminated

Product CodeNSF

Date Initiated2021-02-18

Date Terminated2022-02-24

Product Quantity496 units

Reason for Recall

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

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 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 [email protected], if you have any further questions regarding this field action.

Root Cause

Under Investigation by firm

Distribution Pattern

CA, LA, MN, NC, UT, WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONWako Chemicals USA, Inc. · 2011-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.