FDA Medical Device Recalls (openFDA)
Tosoh Bioscience, Inc.: Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
- Recall number
- Z-0131-06
- Recalling firm
- Tosoh Bioscience, Inc.
- Product
- Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
- Status
- Terminated
- Initiated
- 2005-08-18
- Posted
- 2005-11-15
- Terminated
- 2006-08-25
- Reason
- The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
- Root cause
- Other
- Action
- On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.
- Quantity
- 3,284 boxes
- Distribution
- The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
- Lot, serial or model codes
- Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
- 510(k) numbers
- ["K952720"]
- PMA numbers
- not on file
- Product code
- JPK
- 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