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Terminated

ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

FDA Recall Z-0613-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeNIG
Date Initiated2016-10-19
Date Terminated2023-03-02
Product Quantity30,222 kits

Reason for Recall

CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.

Firm Action

Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue to use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results. For customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended. A Field Correction Effectiveness Check is to be completed, signed and returned Siemens. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative.

Root Cause

Process design

Distribution Pattern

Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031393BAYER ADVIA CENTAUR CA 19-9 ASSAYBayer Healthcare, LLC · 2003-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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