Recall Z-1569-2008 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Laboratories
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 31, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect |
| Root cause | Nonconforming Material/Component |
| Action | Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, d |
| Quantity | 197 units |
| Distribution | Worldwide Distribution --- USA including state of Puerto Rico and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984070 | ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 Bio-Rad, Nov 25, 1998 |