Recall Z-0781-04 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Abbott Laboratories HPD/ADD/GPRD
ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
| Date | Jul 20, 2004 (initiated Mar 23, 2004) |
| Status | Terminated |
| Reason | The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents. |
| Root cause | Other |
| Action | Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers. |
| Quantity | 1,987 kits |
| Distribution | Canada, Australia, Germany and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.