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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Tosoh Bioscience, Inc.
Lot Codes / Batch Numbers
Kit Lot Number: 31205, Controls I & II Lot Numbers: 31009AA, 31010AA
Products Sold
Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
Tosoh Bioscience, Inc. is recalling Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by due to The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
Recommended Action
Per FDA guidance
On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026