Recall Z-0489-2012 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit w/Calibrators 10491379 - 50 Test kit w/Calibrators The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur
| Date | Jan 11, 2012 (initiated Nov 11, 2011) |
| Status | Terminated |
| Reason | Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA Centaur XP systems |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare Diagnostics issued a Urgent Device Notification email dated November 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers conduct a look back if they are using the ADVIA Centaur CA 19-9 interchangeably with the ADVIA Centaur or ADVIA Centaur XP systems and the ADVIA Centaur CP system and to review the contents of the recall notice with their Laboratory Director. A confirmation fax-back form is included to ensure that all customers worldwide have been notif |
| Quantity | 50 Test Kits =21,160; 250 Test Kits = 21,593 |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.