—#105596

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.

FDA product code: NIG — System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device class: Class 2
Medical specialty: Immunology
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-11-11
Posted by FDA: 2012-01-11
Terminated: 2013-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.