Atellica IM eE2 10995561Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00630414598857), received between Jun 19, 2020 and Apr 11, 2026 — classified as 9 injuries, 52 malfunctions.

The most frequently reported specific device problem is “High Test Results” (61 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-1020-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 106. THE CUSTOMER PERFORMED A REVIEW OF EE2 RESULTS AS A PART OF ROUTINE RESET. DURING THIS REVIEW, INITIAL ELEVATED RESULTS WERE OBTAINED FOR TWO (2) PATIENT SAMPLES IN QUESTION. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT WEREN'T QUESTIONED. SUBSEQUENTLY, THE SAME SAMPLES WERE RETESTED ON ALTERNATE ANALYZER(S) WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT BASED ON THE CLINICAL ASSESSMENT. HOWEVER, NO CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851056 ↗
• MalfunctionApr 11, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 106. THE CUSTOMER PERFORMED A REVIEW OF EE2 RESULTS AS A PART OF ROUTINE RESET. DURING THIS REVIEW, INITIAL ELEVATED RESULTS WERE OBTAINED FOR FIVE (5) PATIENT SAMPLES IN QUESTION. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT WEREN'T QUESTIONED. SUBSEQUENTLY, THE SAME SAMPLES WERE RETESTED ON ALTERNATE ANALYZER(S) WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT BASED ON THE CLINICAL ASSESSMENT. HOWEVER, A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN FOR ONLY ONE PATIENT SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850206 ↗
• MalfunctionMar 30, 2026High Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) LOT 106 RESULTS ON(B)(6) 2025 ON SERUM SAMPLES FROM A POSTMENOPAUSAL 63-YEAR-OLD FEMALE. THE ELEVATED ATELLICA IM EE2 RESULTS WERE NOT QUESTIONED AT THE TIME AS THE PATIENT WAS REFERRED TO THIS CUSTOMER SITE FOR CONFIRMATION TESTING ONLY. THE PATIENT WAS LATER TESTED AT A HOSPITAL LABORATORY ((B)(6) 2026) WITH AN ALTERNATE ESTRADIOL METHOD AND A POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY (PET-CT) WAS PERFORMED WITH NO FINDINGS. THE PATIENT ULTIMATELY UNDERWENT OOPHORECTOMY ((B)(6) 2026) AND THE PHYSICIAN WHO PERFORMED THE POST-OPERATIVE CHECK-UP ON THE PATIENT ((B)(6) 2026) BELIEVES THAT THE OOPHORECTOMY WAS AN UNNECESSARY MEDICAL PROCEDURE. SUBSEQUENTLY, SIEMENS HAS BEEN NOTIFIED THAT THE RESULTS OBTAINED BY THIS CUSTOMER ON (B)(6) 2025 ARE NOW IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711772 ↗
• MalfunctionMar 25, 2026High Test Results

  SIEMENS WAS NOTIFIED OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) LOT 107 RESULTS OBTAINED ON SERUM SAMPLES FROM A POSTMENOPAUSAL 63-YEAR-OLD FEMALE. THESE RESULTS WERE OBTAINED PRE AND POST OOPHORECTOMY AND WERE DISCORDANT RELATIVE TO LOWER ALTERNATE METHOD TEST RESULTS AND OTHER DIAGNOSTIC TESTING (POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY (PET-CT) WITH NO FINDINGS IN (B)(6) 2025). THE ATELLICA IM EE2 RESULT OBTAINED PRIOR TO THE OOPHORECTOMY WAS NOT QUESTIONED AT THE TIME. THE PHYSICIAN WHO PERFORMED THE POST-OPERATIVE CHECK-UP ON THE PATIENT ((B)(6) 2026) QUESTIONED THE RESULTS AND BELIEVES THAT THE OOPHORECTOMY WAS AN UNNECESSARY MEDICAL PROCEDURE (OOPHORECTOMY, (B)(6) 2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684147 ↗
• MalfunctionAug 1, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A DIFFERENCE IN SERUM PATIENT SAMPLE RESULTS ON A PATIENT WITH ATELLICA IM ENHANCED ESTRADIOL (EE2) LOT 105 DEPENDING ON WHICH ANCILLARY REAGENT PACK IS USED. INITIAL RESULT USING ONE ANCILLARY PACK WAS HIGHER THAN A RETEST RESULT OBTAINED WITH A DIFFERENT ANCILLARY PACK. THE LOWER RETEST RESULT WAS REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689153 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING EE2 LOT 103. THE CUSTOMER IDENTIFIED QUALITY CONTROL (QC) RESULTS ABOVE EXPECTED RANGES, AND REPEAT-TESTED 172 SAMPLES WHICH HAD BEEN TESTED FOR EE2 SINCE LAST PASSING QC. OBSERVED DIFFERENCES BETWEEN INITIAL AND REPEAT RESULTS RANGED FROM -35% TO +107%; FOR 44 SAMPLES, THE DIFFERENCE WAS 30% OR GREATER. ONLY ONE SAMPLE DEMONSTRATED INITIAL RESULT DEPRESSION. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. RESULT REPORTS WERE CORRECTED FOR ONLY THREE OF THE PATIENTS (SAMPLE IDS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333461 ↗
• MalfunctionJan 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. INITIAL ELEVATED RESULTS WERE OBTAINED FOR FIVE PATIENT SAMPLES. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER AND OBTAINED LOWER RESULTS WHICH WERE CONSIDERED CORRECT AND ISSUED CORRECTED REPORTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, DELAY IN REPORTING THE RESULTS, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167808 ↗
• MalfunctionMay 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THE CUSTOMER OBSERVED EE2 QUALITY CONTROL (QC) RESULTS ABOVE ACCEPTANCE RANGES, AND REPEAT-TESTED SAMPLES WHICH HAD BEEN TESTED WHEN QC WAS OUT. THE INITIAL ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEAT-TESTED AND LOWER RESULTS WERE OBTAINED. ACCORDING TO THE CUSTOMER, NO CORRECTED REPORTS WERE ISSUED SINCE THE RESULTS WERE NOT QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED EE2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375193 ↗
• MalfunctionMay 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE CUSTOMER OBSERVED EE2 QUALITY CONTROL (QC) RESULTS ABOVE ACCEPTANCE RANGES, AND REPEAT-TESTED SAMPLES WHICH HAD BEEN TESTED WHEN QC WAS OUT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEAT-TESTED AND A LOWER RESULT WAS OBTAINED. ACCORDING TO THE CUSTOMER, NO CORRECTED REPORT WAS ISSUED SINCE THE INITIAL RESULT WAS NOT QUESTIONED BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375133 ↗
• MalfunctionApr 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF DISCORDANT ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS OBTAINED ON TWO PATIENT SAMPLES WHILE QUALITY CONTROL (QC) RESULTS WERE OUTSIDE OF RANGES. THE INITIAL ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S); THESE RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLES WERE RETESTED ON AN ALTERNATE ATELLICA IM AND LOWER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095161 ↗
• MalfunctionMar 23, 2024High Test Results; High Test Results

  CUSTOMER REPORTED OBSERVATION OF A DISCORDANT ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT ON ONE PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S); THIS RESULT WAS NOT QUESTIONED. THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM ANALYZER AND OBTAINED A LOWER RESULT. THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965534 ↗
• MalfunctionMar 23, 2024High Test Results; High Test Results

  CUSTOMER REPORTED OBSERVATION OF DISCORDANT ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS ON TWO PATIENT SAMPLES. THE INITIAL ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S); THESE RESULTS WERE NOT QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLES WERE RETESTED ON AN ALTERNATE ATELLICA IM AND LOWER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED EE2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965501 ↗
• MalfunctionMar 23, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS FOR TWO PATIENT SAMPLES WHICH WERE CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE ATELLICA IM ANALYZER WHICH PRODUCED LOWER RESULTS. THE INITIAL ELEVATED RESULTS WERE REPORTED AND NOT QUESTIONED BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S) BASED ON REPEAT TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965378 ↗
• MalfunctionDec 18, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. EE2 REAGENT LOT 097 WAS IN USE AT THE TIME. AN INITIAL EE2 TEST WAS PERFORMED ON A 62-YEAR-OLD MENOPAUSAL FEMALE PATIENT IN NOVEMBER, AND AN ELEVATED RESULT WAS OBTAINED. THE PHYSICIAN QUESTIONED THE HIGH RESULT. THIS DISCORDANT OBSERVATION IS ADRESSED IN THIS REPORT. A NEW SAMPLE WAS DRAWN AND MEASURED ABOUT THREE WEEKS LATER, AND ANOTHER ELEVATED ATELLICA IM EE2 RESULT WAS OBTAINED. THIS SECOND DISCORDANT OBSERVATION IS REPORTED SEPARATELY. THIS SAMPLE WAS SENT TO AN EXTERNAL LAB FOR TESTING BY AN ALTERNATE METHOD, AND A MUCH LOWER RESULT WAS PRODUCED; THIS LOWER RESULT WAS ACCEPTED AS CORRECT. THE SECOND SAMPLE WAS LATER RE-TESTED USING THE SAME ATELLICA IM ANALYZER TO INVESTIGATE. A SIMILAR ELEVATED RESULT WAS OBTAINED, INDICATING THAT THE INITIAL ELEVATED OBSERVATION WAS REPRODUCIBLE. WHEN THIS SAMPLE WAS TESTED USING A SECOND ALTERNATE METHOD, A LOW RESULT ¿ CONCORDANT WITH THAT FROM THE FIRST ALTERNATE METHOD ¿ WAS PRODUCED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346608 ↗
• MalfunctionDec 18, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. EE2 REAGENT LOT 097 WAS IN USE AT THE TIME. AN INITIAL EE2 TEST WAS PERFORMED ON A 62-YEAR-OLD MENOPAUSAL FEMALE PATIENT IN NOVEMBER, AND AN ELEVATED RESULT WAS OBTAINED. THE PHYSICIAN QUESTIONED THE HIGH RESULT. [THIS DISCORDANT OBSERVATION IS REPORTED SEPARATELY.] A NEW SAMPLE WAS DRAWN AND MEASURED ABOUT THREE WEEKS LATER, AND ANOTHER ELEVATED ATELLICA IM EE2 RESULT WAS OBTAINED. [THIS SECOND DISCORDANT OBSERVATION IS ADDRESSED IN THIS REPORT.] THIS SAMPLE WAS SENT TO AN EXTERNAL LAB FOR TESTING BY AN ALTERNATE METHOD, AND A MUCH LOWER RESULT WAS PRODUCED; THIS LOWER RESULT WAS ACCEPTED AS CORRECT. THE SECOND SAMPLE WAS LATER RE-TESTED USING THE SAME ATELLICA IM ANALYZER TO INVESTIGATE. A SIMILAR ELEVATED RESULT WAS OBTAINED, INDICATING THAT THE INITIAL ELEVATED OBSERVATION WAS REPRODUCIBLE. WHEN THIS SAMPLE WAS TESTED USING A SECOND ALTERNATE METHOD, A LOW RESULT ¿ CONCORDANT WITH THAT FROM THE FIRST ALTERNATE METHOD ¿ WAS PRODUCED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346598 ↗
• MalfunctionNov 17, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. EE2 REAGENT LOT 096 WAS IN USE AT THE TIME. AN INITIAL ELEVATED EE2 RESULT WAS OBTAINED FOR A 38-YEAR-OLD FEMALE PATIENT WHO IS ON ENDOCRINE THERAPY WITH HORMONE SUPPRESSION (LUCRIN INJECTION). THIS RESULT WAS REPORTED, AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS TESTED AGAIN ON THE ORIGINAL INSTRUMENT FOLLOWING ASSAY RECALIBRATION, AND A LOWER RESULT WAS PRODUCED. THE TEST WAS REPEATED USING THE SAME METHOD AT ANOTHER SITE, AND A SIMILAR LOWER RESULT WAS OBTAINED. AN ADDITIONAL TEST (USING THE SAME METHOD) AT ANOTHER SISTER SITE PRODUCED A THIRD RESULT WHICH AGREED WITH THE OTHER LOWER RESULTS. THE LOWER RESULT OBTAINED IN THE LOCAL LAB WAS REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165522 ↗
• MalfunctionSep 28, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED RESULTS ON THE ATELLICA IM ENHANCED ESTRADIOL (EE2) ASSAY WITH REAGENT LOT 096 COMPARED TO REPEAT TESTING. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED EE2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839694 ↗
• MalfunctionApr 19, 2023High Test Results; High Test Results

  DUE TO QUALITY CONTROL RESULTS ON (B)(6) 2023 WITH ATELLICA IM ENHANCED ESTRADIOL LOT 090, THE CUSTOMER REPEATED SAMPLES. THE CUSTOMER REPORTS OBSERVED DISCORDANT ELEVATED RESULTS WHEN RUNNING ATELLICA IM ENHANCED ESTRADIOL COMPARED TO REPEAT TESTING OF THE SAMPLES ON ATELLICA IM ANALYZERS WITH LOT 092. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768625 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  A CUSTOMER REPORTED OBSERVATION OF FALSELY-ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS. THE CUSTOMER EXPERIENCED A QUALITY CONTROL (QC) EXCURSION ON (B)(6) 2023, WHEN RUNNING ATELLICA IM EE2. PATIENT SAMPLES WHICH HAD BEEN TESTED SINCE LAST PASSING QC WERE REPEAT-TESTED ON ANOTHER ATELLICA IM ANALYZER, USING A DIFFERENT REAGENT LOT. FOLLOWING THE REPEAT TESTING, SOME SAMPLES WERE IDENTIFIED AS DISCORDANT, WHERE THE INITIAL RESULT WAS ELEVATED RELATIVE TO THE REPEAT RESULT. THE REPEAT-TEST RESULTS (WITH PASSING QC) WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763151 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  A CUSTOMER REPORTED OBSERVATION OF FALSELY-ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULTS. THE CUSTOMER EXPERIENCED A QUALITY CONTROL (QC) EXCURSION ON (B)(6) 2023, WHEN RUNNING ATELLICA IM EE2. PATIENT SAMPLES WHICH HAD BEEN TESTED SINCE LAST PASSING QC WERE REPEAT-TESTED ON ANOTHER ATELLICA IM ANALYZER, USING A DIFFERENT REAGENT LOT. FOLLOWING THE REPEAT TESTING, SOME SAMPLES WERE IDENTIFIED AS DISCORDANT, WHERE THE INITIAL RESULT WAS ELEVATED RELATIVE TO THE REPEAT RESULT. THE REPEAT-TEST RESULTS (WITH PASSING QC) WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763150 ↗
• MalfunctionApr 13, 2023High Test Results; High Test Results

  DUE TO QUALITY CONTROL RESULTS ON MARCH 16, 2023 WITH ATELLICA IM ENHANCED ESTRADIOL LOT 090, THE CUSTOMER REPEATED SAMPLES. THE CUSTOMER REPORTS OBSERVED DISCORDANT ELEVATED RESULTS WHEN RUNNING ATELLICA IM ENHANCED ESTRADIOL COMPARED TO REPEAT TESTING OF THE SAMPLES ON ALTERNATE ATELLICA IM ANALYZERS WITH LOT 092. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730747 ↗
• MalfunctionApr 12, 2023High Test Results; High Test Results

  DUE TO QUALITY CONTROL RESULTS ON (B)(6) 2023 WITH ATELLICA IM ENHANCED ESTRADIOL LOT 090, THE CUSTOMER REPEATED SAMPLES. THE CUSTOMER REPORTS OBSERVED DISCORDANT ELEVATED RESULTS WHEN RUNNING ATELLICA IM ENHANCED ESTRADIOL COMPARED TO REPEAT TESTING OF THE SAMPLES ON ALTERNATE ATELLICA IM ANALYZERS WITH LOT 092. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725315 ↗
• MalfunctionMar 31, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCORDANT PATIENT SAMPLE RESULTS WHEN RUNNING ENHANCED ESTRADIOL (EE2) LOT 090 ON AN ATELLICA IM ANALYZER. THE INITIAL PATIENT RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE SAME DAY WERE REPORTED TO PHYSICIAN(S) AND WERE NOT QUESTIONED. THE CUSTOMER OBSERVED UNACCEPTABLE CONTROL PERFORMANCE AND THE PATIENT SAMPLES WERE RETESTED ON THE SAME DAY, ON A DIFFERENT ATELLICA IM ANALYZER. THE RETEST RESULTS WERE LOWER THAN THE INITIAL RESULTS AND WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S) 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 16658199 ↗
• MalfunctionMar 16, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM ENHANCED ESTRADIOL RESULTS FOR FIVE PATIENT SAMPLES THAT WERE CONSIDERED DISCORDANT TO REPEAT TESTING ON THE ATELLICA IM ENHANCED ESTRADIOL ASSAY. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCORDANT ELEVATED ATELLICA IM ENHANCED ESTRADIOL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16557573 ↗
• MalfunctionNov 15, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY-ELEVATED ATELLICA IM ENHANCED ESTRADIOL (EE2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE CUSTOMER OBTAINED AN ELEVATED EE2 RESULT FOR AN ONCOLOGY PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING MASS SPECTROMETRY (MS). IT WAS NOTED THAT THE PATIENT WAS TAKING THE MEDICATION ZOLADEX. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED NOR OF ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799278 ↗