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
FDA Recall Z-1477-2011 · Posted 2011-03-02
Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeLTK
Date Initiated2010-12-14
Date Terminated2013-04-12
Product Quantity2960 units
Reason for Recall
Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal
Firm 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 questions, please contact the Technical Solutions Center at 1-877-229-3711
Root Cause
Process control
Distribution Pattern
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, Singapore, Slovakia, South Africa, Spain, Sweden, Czech Republic, Taiwan, Turkey, Uganda, and Venezuela
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.