Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Brand
Siemens Healthcare Diagnostics, Inc
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Siemens Healthcare Diagnostics, Inc is recalling Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:1031030 due to Homocysteine Assay May Cause Elevated Results in the Folate Assay. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Recommended Action
Per FDA guidance
Siemens issued Urgent Medical Device Correction, CC 19-07.A.US to customers on July 22, 2019 to be delivered to customers on July 23, 2019. After release of the letter (CC 19-07.A.US), we identified a typographical error in Table 1, specifically the Reference kit SMN (19331250). Version B (CC 19-07-B.US) is being created with the corrected SMN Number (10331250) and distributed to the reference accounts that order SMN (Quest Diagnostics). Urgent Field Safety Notice, CC 19-07.A.OUS was sent out to the country organizations on July 19, 2019 for distribution to customers outside the United States. The customer distribution included all customers that have received both ADVIA Centaur Folate and ADVIA Centaur Homocysteine over the past year. The letters inform customers the potential for the ADVIA Centaur Homocysteine assay to cause elevated Folate results when an ADVIA Centaur Folate test immediately follows an ADVIA Centaur Homocysteine test. The communications provide recommendations to run the assays on different ADVIA Centaur systems or on other Siemens Healthcare systems or to test all Homocysteine samples together followed by the Daily Cleaning Procedure prior to testing the Folate assay to mitigate the interference. Field Correction Effectiveness Check form provided. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative. Update: 11/30/20 Siemens issued Follow Up Customer Notification CC 19-07.C.US and or CC 19-07.B.OUS, dated Dec.1, 2020 via overnight to US customers on December 1st, 2020 and Siemens EU Authorized Representatives issued the letter to OUS countries on December 1st, 2020, stating:Siemens has implemented a new wash mitigation into ADVIA Centaur XPT Folate (FOL) Test Definition (TDef) Version 2.1 and ADVIA Centaur XPT Homocysteine (HCY) TDef Version 1.5 for use on the ADVIA Centaur XPT system and TDef Version EL/EM on the ADVIA Centaur XP system. Actions to be Taken by the Custome
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026