Atellica™ IM Fol 10995573Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414598970), received between Oct 14, 2022 and Jun 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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-1150-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT ELEVATED RESULT WHEN RUNNING ATELLICA IM 1600 FOLATE, LOT 343. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAY IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085152 ↗
• MalfunctionJun 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED RESULT FOR THE ATELLICA IM FOLATE (FOL) ASSAY WHICH WAS CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT FOR A PATIENT SAMPLE. THE INITIAL RESULT WAS REPORTED AND WAS NOT QUESTIONED BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083108 ↗
• MalfunctionOct 14, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED QUALITY CONTROLS (QC) RESULTS AND A PATIENT SAMPLE RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING, WHEN USING THE FOLATE (FOL) ASSAY ON THE ATELLICA IM 1600. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. 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 15606944 ↗

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-1149-2023 · Jan 9, 2023 · Open, Classified
  Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 1099557