Atellica IM eE2 10995562Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414598864), received between Dec 17, 2021 and Apr 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

1 FDA recall record name this device's identifier, 1 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, 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. Mar 3, 2022Class IIOpen, Classified

   Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

   Z-1021-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ENHANCED ESTRADIOL (EE2), LOT 090, INITIAL RESULT FOR SERUM SAMPLE TESTED ON AN ATELLICA IM (B)(6). THE RESULT WAS CONSIDERED DISCORDANT COMPARED TO THE LOWER RETEST RESULT OBTAINED ON A DIFFERENT DAY ON A DIFFERENT ATELLICA IM ANALYZER. THE INITIAL PATIENT RESULT HAD BEEN REPORTED, BUT NOT QUESTIONED BY PHYSICIAN(S) AT THE TIME. A CORRECTED REPORT WAS ISSUED AFTER RETESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792070 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ENHANCED ESTRADIOL (EE2), LOT 090, INITIAL RESULTS FOR SERUM SAMPLES TESTED ON AN ATELLICA IM 1600 ANALYZER (S/N (B)(4)). THE SAMPLES WERE FROM DIFFERENT PATIENTS. THE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE LOWER RETEST RESULTS OBTAINED ON DIFFERENT DAYS ON DIFFERENT ATELLICA IM ANALYZERS WITH LOT 092. THE INITIAL PATIENT RESULTS HAD BEEN REPORTED, BUT NOT QUESTIONED BY PHYSICIAN(S) AT THE TIME. CORRECTED REPORTS WERE ISSUED AFTER RETESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EE2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765551 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ENHANCED ESTRADIOL (EE2), LOT 090, INITIAL RESULT FOR A SERUM SAMPLE TESTED ON AN ATELLICA IM 1600 ANALYZER (S/N (B)(4)). THE RESULT WAS CONSIDERED DISCORDANT COMPARED TO THE LOWER RETEST RESULT OBTAINED ON A DIFFERENT DAY ON A DIFFERENT ATELLICA IM ANALYZER WITH LOT 092. THE INITIAL PATIENT RESULT WAS REPORTED, BUT NOT QUESTIONED BY THE PHYSICIAN AT THE TIME. A CORRECTED REPORT WAS ISSUED AFTER RETESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765485 ↗
• MalfunctionDec 17, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT, FALSELY-ELEVATED ATELLICA IM ENAHNCED ESTRADIOL (EE2) RESULT FOR ONE PATIENT. REPEAT TESTING PRODUCED A LOWER RESULT WHICH WAS ACCEPTED AS CORRECT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED, OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY-ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026288 ↗