Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 67
FDA device recall Z-1385-06 · posted 2006-08-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)
- Action taken
- Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GTQ
- Quantity affected
- 20 kits.
- Distribution
- Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.
- Date initiated
- 2006-07-25
- Date posted
- 2006-08-09
- Date terminated
- 2007-04-18
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.