Z-0131-06

Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH...

Name: Z-0131-06 Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH...
Creator: Tosoh Bioscience, Inc.
Published: 2005-08-18
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2005-08-18 / Terminated

FDA source

Tosoh Bioscience, Inc. began a recall of Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201... on 2005-08-18. The reason FDA records is "The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0131-06
Status: Terminated
Initiated: 2005-08-18
Posted: 2005-11-15
Terminated: 2006-08-25
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.
Product code: JPK Mixture, Hematology Quality Control
Reason for recall: The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
FDA 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 in commerce: 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.
Product codes and lots: Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA

Product code JPK

K952720Class IIAalto Scientific Ltd. Glycated Hemoglobin Control Levels I & IIAalto Scientific, Ltd. / cleared 1995-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)