Recall Z-0680-03 ยท MOI System, Test, Immunological, Antigen, Tumor
Abbott Laboratories HPD/ADD
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 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 | 792 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 |