Recall Z-0679-03 ยท MOI System, Test, Immunological, Antigen, Tumor
Abbott Laboratories HPD/ADD
Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064
| Date | Mar 26, 2003 (initiated Mar 4, 2003) |
| Status | Terminated |
| Reason | The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens. |
| Root cause | Other |
| Action | Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory. |
| Quantity | 958 packs |
| Distribution | Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963926 | AXSYM CA 15-3 Abbott Laboratories, Sep 15, 1997 |