Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

Recall number

Z-0831-2020

Recalling firm

Siemens Healthcare Diagnostics, Inc

Product

Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

Status

Terminated

Initiated

2019-07-22

Posted

2020-01-21

Terminated

2025-02-14

Reason

Homocysteine Assay May Cause Elevated Results in the Folate Assay

Root cause

Device Design

Action

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

Quantity

3,627 kits

Distribution

Nationwide Foreign: Armenia¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sudan¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿

Lot, serial or model codes

All lots

510(k) numbers

["K010050"]

PMA numbers

not on file

Product code

CGN

Firm FEI

1219913

Firm city

East Walpole

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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