Z-0489-2012

ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50...

Name: Z-0489-2012 ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2011-11-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-11-11 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit... on 2011-11-11. The reason FDA records is "Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA...". 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-0489-2012
Status: Terminated
Initiated: 2011-11-11
Posted: 2012-01-11
Terminated: 2013-04-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit w/Calibrators 10491379 - 50 Test kit w/Calibrators The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Reason for recall: Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA Centaur XP systems
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare Diagnostics issued a Urgent Device Notification email dated November 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers conduct a look back if they are using the ADVIA Centaur CA 19-9 interchangeably with the ADVIA Centaur or ADVIA Centaur XP systems and the ADVIA Centaur CP system and to review the contents of the recall notice with their Laboratory Director. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action For further questions please call (508) 359.3825.
Quantity in commerce: 50 Test Kits =21,160; 250 Test Kits = 21,593
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada.
Product codes and lots: Reagent Lot # Expiry Date XXXXX294 11-Aug-11 XXXXX296 6-Oct-11 XXXXX298 6-Nov-11 XXXXX299 6-Nov-11 XXXXX302 9-Jan-12 XXXXX303 9-Jan-12 XXXXX305 18-Feb-12 XXXXX306 3-Apr-12 XXXXX307 3-Apr-12 XXXXX308 3-Apr-12 XXXXX309 3-Jun-12 XXXXX311 30-Jun-12

Product code NIG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)