Recall Z-0322-04 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Abbott Laboratories HPD/ADD/GPRD
CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jan 10, 2004 (initiated Nov 25, 2003) |
| Status | Terminated |
| Reason | The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4 |
| Root cause | Other |
| Action | Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls. |
| Distribution | Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Ur |
| FDA record | Open on fda.gov |