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.
FDA Recall Z-0131-06 · Posted 2005-11-15
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Recalling FirmTosoh Bioscience, Inc.
Recall StatusTerminated
Product CodeJPK
Date Initiated2005-08-18
Date Terminated2006-08-25
Product Quantity3,284 boxes
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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