ADVIA Centaur FOLRecalls & reported problems across all models

We found 3 models of ADVIA Centaur FOL by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2017 and Feb 17, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Readings” (1 report).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ADVIA Centaur FOL recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 9, 2023Open, Classified

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

   Z-1154-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 9, 2023Open, 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 ↗

3. Jan 9, 2023Open, Classified

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

   Z-1152-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported ADVIA Centaur FOL problems

ADVIA Centaur FOL models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® FOL 10310308

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall3 reports
• ADVIA Centaur® FOL 10325366

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall1 report
• ADVIA Centaur® FOL 10331250

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall0 reports

Recent ADVIA Centaur FOL adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2020High Readings; No Apparent Adverse Event; High Readings; No Apparent Adverse Event

  DISCORDANT ADVIA CENTAUR XPT FOLATE (FOL) RESULTS WERE OBTAINED ON PATIENT SAMPLES AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER OBSERVED CLUMPING IN THE REAGENT READYPACK, AND PERFORMED REPEAT FOLATE TESTING ON AN ALTERNATE ADVIA CENTAUR SYSTEM. THE REPEAT FOLATE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT FOLATE (FOL) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717705 ↗
• MalfunctionMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP FOLATE (FOL) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO LOWER DILUTION RESULTS, AND A NORMAL VITAMIN B12. THE FALSELY ELEVATED FOLATE RESULT WAS NOT REPORTED TO THE PROVIDER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CENTAUR XP FOLATE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317605 ↗
• MalfunctionNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XPT FOLATE RESULTS WERE OBTAINED ON A PATIENT SAMPLE BETWEEN NEAT AND DILUTION, THE INITIAL RESULT WAS GREATER THAN 24 NG/ML. A NEW SAMPLE WAS COLLECTED AFTER THE PATIENT HAD STOPPED TAKING CYSTINE-B6. THE NEW SAMPLE WAS TESTED AND THE RESULTS WERE LOWER. THE OLD SAMPLE WAS REPEATED NEAT AND DILUTED. THE RESULTS WERE LOWER WITH DILUTION. THE HBT (HETEROPHILIC BLOCKING TUBE) / NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) TESTING WAS PERFORMED A NEW SAMPLE WAS COLLECTED ON (B)(6) 2017 AFTER THE PATIENT STOPPED TAKING CYSTINE-B6. 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 7033313 ↗
• 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 ↗

Other Siemens Healthcare Diagnostics Inc. products

• Atellica IM TNIH2 models · 629 reports
• Dimension EXL 200 Integrated Chemistry System2 models · 516 reports · 1 recall
• Atellica IM CA 19-93 models · 121 reports · 3 recalls
• ADVIA Centaur XP Analyzer2 models · 269 reports
• ADVIA Centaur CA 19-92 models · 124 reports · 2 recalls
• Atellica IM eE23 models · 65 reports · 3 recalls
• RAPIDPoint 500 Measurement Cartridge4 models · 3 reports · 4 recalls
• ADVIA Centaur eE23 models · 22 reports · 3 recalls