Atellica™ IM Fol 10995572Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414598963), received between Sep 30, 2019 and Dec 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K172201); 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 18, 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-1149-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT ELEVATED ATELLICA IM FOLATE RESULTS FOR TWO PATIENTS. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS.  THE SAME SAMPLES WERE REPEATED USING FOLSERUM ON THE SAME ATELLICA IM ANALYZER, AND THE RESULTS WERE LOW. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015775 ↗
• MalfunctionNov 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED PATIENT SAMPLE RESULT WHEN USING ATELLICA IM 1300 FOLATE (FOL) ASSAY. AFTER REPEATING WITH DILUTION, THE RESULTS WERE SIGNIFICANTLY LOWER THAN THE INITIAL RESULT. IT IS UNKNOWN WHICH RESULT IS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852262 ↗
• MalfunctionNov 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM FOLATE (FOL) RESULT THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707418 ↗
• MalfunctionOct 31, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM FOLATE (FOL) RESULT THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699338 ↗
• MalfunctionOct 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM FOLATE (FOL) RESULT THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FOLATE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690551 ↗
• MalfunctionMay 17, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ATELLICA IM FOLATE RESULT COMPARED TO REPEAT TESTING. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM FOLATE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838661 ↗
• MalfunctionSep 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT ATELLICA IM FOLATE RESULTS WERE OBTAINED ON SAMPLES FROM THREE PATIENTS WHEN COMPARING RESULTS BETWEEN REAGENT LOT 289 AND PREVIOUS LOT 286. 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 9134972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172201. One submission often covers many models, so check the product and lot details in each record.

• Z-1151-2023 · Jan 9, 2023 · Open, Classified
  Atellica IM Folate 700 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): 112
• Z-1150-2023 · Jan 9, 2023 · Open, Classified
  Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573