Z-1477-2011

ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows

Name: Z-1477-2011 ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2010-12-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-12-14 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of 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... on 2010-12-14. The reason FDA records is "Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1477-2011
Status: Terminated
Initiated: 2010-12-14
Posted: 2011-03-02
Terminated: 2013-04-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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
Root cause tag: manufacturing process
FDA 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 questions, please contact the Technical Solutions Center at 1-877-229-3711
Quantity in commerce: 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, Singapore, Slovakia, South Africa, Spain, Sweden, Czech Republic, Taiwan, Turkey, Uganda, and Venezuela
Product codes and lots: Lot Code: 144 Affected kit lot numbers: 62431144, 63124144, 63519144, 63876144, 62450144 and 63822144 Expiry Date: 15 September 2011

Product code LTK

K020828Class IICa 125 Assay for the Advia Centaur SystemBayer Corp. / cleared 2002-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)