Recall Z-1477-2011 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit
| Date | Mar 2, 2011 (initiated Dec 14, 2010) |
| Status | Terminated |
| Reason | Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal |
| Root cause | Process control |
| Action | Siemens Healthcare Diagnostics on 12 /14/10 issued Urgent Device Recall notice via Federal Express to accounts. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Device Recall notice directs customers to immediately discontinue the use of ADVIA Centaur CA 125 II assay kits that contain CA 125 II reagent lot 144. It also recommends that patient results obtained with this reagent lot be reviewed. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Technical |
| Quantity | 2960 units |
| Distribution | Worldwide distribution, including USA, Canada, Argentina, Austria, Belgium, China, Denmark, France, Germany, Great Britain, Greece, India, Italy, Japan, Korea, Lavitia, Lithuania, Malyasia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Switzerland, Serbia, |
| 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 |