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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens, Atellica IM Folate, ADVIA Centaur Folate

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 Class 2 Device Recall Siemens, Atellica IM Folate, ADVIA Centaur Folatesee related information
Date Initiated by FirmJanuary 09, 2023
Date PostedFebruary 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1152-2023
Recall Event ID 91522
510(K)NumberK010050 
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
ProductADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
Code Information UDI: (01)00630414204192(10)16275336(17)20230320; (01)00630414204192(10)21333336(17)20230320; (01)00630414204192(10)22318336(17)20230320; (01)00630414204192(10)23066336(17)20230320; (01)00630414204192(10)27947338(17)20230529; (01)00630414204192(10)62967344(17)20230726. Lot Numbers: 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactSAME
508-668-5000
Manufacturer Reason
for Recall
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
FDA Determined
Cause 2
Under Investigation by firm
ActionSiemens Healthineers issued Urgent Medical Device Corrections (UMDC AIMC 23-03.A-1.US and AIMC 23-03.A-2.US) to US customers and Urgent Field Safety Notices (UFSN AIMC 23-03.A-1.OUS and AIMC 23-03.A-2.OUS) to customers outside the United States. The UMDCs and UFSNs advise customers to use the appropriate FolSerum calibration instructions when testing serum samples with Atellica IM Folate kit lots ending in 337 and above or ADVIA Centaur Folate kit lots ending in 336 and above. Letter states reason for recall, health risk and action to take: Follow the instructions in this Urgent Medical Device Correction until the Atellica IM Folate/ADVIA Centaur Folate Instructions for Use are updated. o Before updating to the new reagent lot, ensure you have processed all serum samples necessary for lot-to-lot comparisons using your existing inventory. o Once you have updated to the new reagent lot, you will not be able to process serum samples with the previous reagent lot. o If your laboratory runs both serum and whole blood sample types, then both assays must be calibrated with the new reagent lot. o If your laboratory runs one sample type, only calibrate the sample type you use If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in Commerce14,669 kits
DistributionNationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Kenya¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Malta¿¿¿¿¿¿¿¿¿¿ Morocco¿¿¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Oman¿¿¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ Uganda¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿ Country AR AU BR BS CA CL CN CO CR DO EC HK IL IN JP KR MX MY NZ PE PH PY SA SG TH TW UY VN ZA
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJX
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