Recall Z-1539-05 ยท DIF Drug Mixture Control Materials
Abbott Laboratories MPG
XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA
| Date | Sep 14, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| Reason | The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay. |
| Root cause | Other |
| Action | On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the contro |
| Quantity | 4151 kits |
| Distribution | Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Barbados, Bermuda, Brazil, Canada, Cayman Island, Chile, China/Hong Kong, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Germany, Honduras, Jamaica, Korea, Mexico, New Zealand, Panama, Peru, Singapore, St. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K873183 | TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS Abbott Laboratories, Nov 23, 1987 |