FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: TASWako Chip Cassette is part of the Wako TASWako i30 kit
- Recall number
- Z-1412-2021
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- TASWako Chip Cassette is part of the Wako TASWako i30 kit
- Status
- Terminated
- Initiated
- 2021-02-18
- Posted
- not on file
- Terminated
- 2022-02-24
- 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 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.
- Quantity
- 496 units
- Distribution
- CA, LA, MN, NC, UT, WI
- Lot, serial or model codes
- Lot Number: EQ194 Exp. Date: 05/31/2022
- 510(k) numbers
- K100464
- PMA numbers
- not on file
- Product code
- NSF
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28