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.
This recall has been terminated (originally issued November 15, 2005).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- August 18, 2005
- Posted
- November 15, 2005
- Terminated
- August 25, 2006
- Recall Number
- Z-0131-06
- Quantity
- 3,284 boxes
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
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.
Distribution
The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
Lot / Code Info
Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
Root Cause
Other
Action Taken
On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.
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