Recall Z-1904-2012 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Abbott Laboratories
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be use
| Date | Jun 29, 2012 (initiated May 30, 2012) |
| Status | Terminated |
| Reason | The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required" letter dated May 30, 2012 to all Architect CA 19-9XR customers who received the affected reagent lots. The customers were directed to immediately discontinue use and destroy any remaining inventory of the lots listed; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom th |
| Quantity | 316 kits - USA, 8,356 kits ROW |
| Distribution | Worldwide Distribution - US (nationwide) the states of: Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington, including Puerto Rico, and the countries of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052000 | ARCHITECT CA 19-9XR ASSAY Fujirebio Diagnostics,Inc., Oct 25, 2005 |