Atellica IM FolRecalls & reported problems across all models

We found 3 models of Atellica IM Fol by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2019 and Jun 8, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

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

Atellica IM 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-1151-2023 · 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-1150-2023 · 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-1149-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Atellica IM Fol problems

Atellica IM Fol models

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

• Atellica™ IM Fol 10995572

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall7 reports
• Atellica™ IM Fol 10995573

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall3 reports
• Atellica IM Fol 11206252

  ACID, FOLIC, RADIOIMMUNOASSAY
  1 recall0 reports

Recent Atellica IM Fol adverse event reports

The 10 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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