Recall Z-0612-2017 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens p
| Date | Oct 19, 2016 |
| Status | Terminated |
| Reason | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use. |
| Root cause | Process design |
| Action | Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue to use the ADVIA Centaur CA 19-9 assay to report patie |
| Quantity | 18,733 kits |
| Distribution | Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Gr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC, Jun 24, 2003 |