—#96186

Product

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 product code: LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K020828
Affected lot / code info: Lot Code: 144 Affected kit lot numbers: 62431144, 63124144, 63519144, 63876144, 62450144 and 63822144 Expiry Date: 15 September 2011

Why it was recalled

Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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

Timeline

Recall initiated: 2010-12-14
Posted by FDA: 2011-03-02
Terminated: 2013-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.