Recall Z-0400-06 ยท DDR Myoglobin, Antigen, Antiserum, Control
Abbott Laboratories MPG
ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
| Date | Jan 18, 2006 (initiated Oct 17, 2005) |
| Status | Terminated |
| Reason | Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen. |
| Root cause | Other |
| Action | Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. Ho |
| Quantity | 11 kits |
| Distribution | Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042920 | HOVEROUND SE-3 POWERCHAIR Hoveround Corp., Dec 3, 2004 |