FDA Medical Device Recalls (openFDA)
Tosoh Bioscience, Inc.: AIA-PACK TPOAb CONTROL SET
- Recall number
- Z-2168-2017
- Recalling firm
- Tosoh Bioscience, Inc.
- Product
- AIA-PACK TPOAb CONTROL SET
- Status
- Terminated
- Initiated
- 2017-02-08
- Posted
- 2017-05-15
- Terminated
- 2019-02-08
- Reason
- The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
- Root cause
- Labeling mix-ups
- Action
- On 3/3/2017 the firm sent recall notificaion letters to their customers.
- Quantity
- 15 boxes
- Distribution
- Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- Lot, serial or model codes
- TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
- 510(k) numbers
- ["K981521"]
- PMA numbers
- not on file
- Product code
- JZO
- Firm FEI
- 1000123732
- Firm city
- South San Francisco
- Firm state
- CA
- 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