Recall Z-1486-2018 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
| Date | Feb 21, 2018 |
| Status | Terminated |
| Reason | Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. |
| Root cause | Other |
| Action | A Customer Notification was sent to customers on 2/21/18. The letter instructs customers to refer to the information provided until the appropriate updates are available in the assay instructions for use. The letter is to be retained and forwarded to those who may have received the product. |
| Quantity | SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits |
| Distribution | US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Corp., Jul 24, 2002 |