Recall Z-1319-2008 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
BD Diagnostic Systems / Lee Laboratories
DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
| Date | Sep 11, 2008 (initiated Aug 8, 2007) |
| Status | Terminated |
| Reason | Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism. |
| Root cause | Nonconforming Material/Component |
| Action | Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification. |
| Quantity | 26 units |
| Distribution | Nationwide Distribution and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.