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Open, Classified

ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366

FDA Recall Z-1154-2023 · Posted 2023-02-21

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeJJX
Date Initiated2023-01-09
Product Quantity124 kits

Reason for Recall

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Firm Action

Siemens 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.

Root Cause

Under Investigation by firm

Distribution Pattern

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Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010050ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAYBayer Diagnostics Corp. · 2001-02-05

Official Source

View FDA Recall →

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

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