Recall Z-0131-06 ยท JPK Mixture, Hematology Quality Control
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.
| Date | Nov 15, 2005 (initiated Aug 18, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952720 | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II Aalto Scientific, Ltd., Sep 20, 1995 |