Recall Z-1222-2007 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Laboratories
ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL
| Date | Sep 18, 2007 (initiated Jul 6, 2007) |
| Status | Terminated |
| Reason | The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual. |
| Root cause | Other |
| Action | Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will cont |
| Quantity | 57 kits |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984324 | ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 Bio-Rad, Dec 15, 1998 |