FDA Medical Device Recalls (openFDA)
Tosoh Bioscience Inc: TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels.
- Recall number
- Z-0558-06
- Recalling firm
- Tosoh Bioscience Inc
- Product
- TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels.
- Status
- Terminated
- Initiated
- 2006-01-26
- Posted
- 2006-02-23
- Terminated
- 2008-10-24
- Reason
- The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.
- Root cause
- Other
- Action
- The recalling firm sent a letter, dated 1/26/06, to all consignees.
- Quantity
- 9 boxes
- Distribution
- KS, GA, TX, WI
- Lot, serial or model codes
- Lot #FX17440. The inner foil packs contain an ''incorrect'' expiration date of 10/2005. The outer box is labeled with the ''correct'' expiration date of 10/2006.
- 510(k) numbers
- ["K936229"]
- PMA numbers
- not on file
- Product code
- CDP
- Firm FEI
- 3005529799
- Firm city
- Grove City
- Firm state
- OH
- 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