Recall Z-1244-06 ยท MOI System, Test, Immunological, Antigen, Tumor
Abbott Laboratories MPG
CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 18, 2006 (initiated Jun 9, 2006) |
| Status | Terminated |
| Reason | The CA 15-3 Controls replicates out of range high resulting in invalid runs. |
| Root cause | Other |
| Action | Abbott initiated a field correction recall by letter dated 6/9/06 and sent on 6/12/06 to all customers receiving the affected controls. The accounts were informed of the increase in invalid runs due to controls outside of the package insert range with this lot of CA 15-3 Controls. The accounts were requested to assess the inventory for the affected lot of controls, discontinue use of the lot and destroy the remaining inventory of the lot, recording the number of kits on the customer reply form and faxing it to Abbott by 6/21/06, indicating that the letter was received and understood. Credit w |
| Quantity | 1794 kits |
| Distribution | Worldwide, including U.S.A., Puerto Rico, Canada, Mexico, Ecuador, Chile, Argentina, Brazil, Germany, Japan, SIngapore, Hong Kong, Thailand, South Korea and Australia. |
| FDA record | Open on fda.gov |