Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc.
FDA device recall Z-0131-06 · posted 2005-11-15 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 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.
- Date initiated
- 2005-08-18
- Date posted
- 2005-11-15
- Date terminated
- 2006-08-25
- Location
- South San Francisco, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II (K952720) | Aalto Scientific, Ltd. | 1995-09-20 |