ADVIA Centaur® FOL 10325366Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414450940), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 malfunction.

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K010050); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 9, 2023Class IIOpen, Classified

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

   Z-1153-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XP FOLATE RESULTS WERE OBTAINED ON A PATIENT SAMPLE BETWEEN NEAT AND DILUTION, THE INITIAL RESULT WAS GREATER THAN 24 NG/ML. THE SAMPLE WAS DILUTED AND TESTED MULTIPLE TIMES. THE RESULTS WERE LOWER WITH DILUTION. THE SAMPLE WAS TESTED AGAIN DILUTED ON A SECOND ADVIA CENTAUR XP AND THE RESULT WAS LOWER THAN THE NEAT RESULT. THE DILUTED RESULTS WERE CONSIDERED CORRECT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789785 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010050. One submission often covers many models, so check the product and lot details in each record.

• Z-1152-2023 · Jan 9, 2023 · Open, Classified
  ADVIA 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): 1031030
• Z-1154-2023 · Jan 9, 2023 · 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): 1
• Z-0829-2020 · Jul 22, 2019 · Terminated
  Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
• Z-0830-2020 · Jul 22, 2019 · Terminated
  Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
• Z-0831-2020 · Jul 22, 2019 · Terminated
  Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
• Z-1689-2018 · Jan 2, 2018 · Terminated
  ADVIA Centaur Folate (FOL)
• Z-2739-2015 · Jul 27, 2015 · Terminated
  ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
• Z-1564-2014 · Mar 25, 2014 · Terminated
  Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 S
• Z-2170-2013 · Jul 25, 2013 · Terminated
  ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
• Z-2171-2013 · Jul 25, 2013 · Terminated
  ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
• Z-2172-2013 · Jul 25, 2013 · Terminated
  ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
• Z-2169-2013 · Jul 25, 2013 · Terminated
  ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
• Z-0511-2013 · Nov 14, 2012 · Terminated
  Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For