IMMULITE®/IMMULITE® 1000 Systems ACT ACTH 10381415Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414963532), received between Sep 25, 2019 and Nov 7, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION CITED BY THE FDA BASED ON RECENT COMMUNICATIONS ABOUT THE IMMULITE ADRENOCORTICOTROPIC HORMONE (ACTH) ASSAY, TITLED "A DIAGNOSTIC CONUNDRUM: HETEROPHILIC ANTIBODY INTERFERENCE IN AN ADRENOCORTICOTROPIC HOMRONE IMMUNOASSAY NOT DETECTABLE USING A PROPRIETARY HETEROPHILE BLOCKING REAGENT" DATED APRIL 2, 2013 BY "JONATHAN GRASKO ET.AL." THE ARTICLE STATES THAT A RETIRED (B)(6) YEAR OLD RETIRED FEMALE NURSE UNDERWENT EXTENSIVE INVASIVE INVESTIGATIONS, WHICH WERE ULTIMATELY UNNECESSARY, AS A RESULT OF INITIAL ANALYTICAL INTERFERENCE IN THE IMMULITE 2000 XPI ACTH ASSAY, WHICH COULD NOT BE RESOLVED USING A PROPRIETARY HETEROPHILIC BINDING REAGENT. THE PATIENT HAD A HISTORY OF HYPERTENSION AND DEPRESSIVE ILLNESS PRESENTED FOLLOWING THE DIAGNOSIS AND TREATMENT OF BREAST CANCER WHICH WAS DEEMED TO BE IN CLINICAL REMISSION. THE PATIENT WAS NOTED TO HAVE BILATERAL ADRENAL GLAND ENLARGEMENT ON A RECENT ABDOMINAL CT SCAN. ON INITIAL PRESENTATION, THERE WERE A FEW CLINICAL FEATURES SUGGESTIVE OF GLUCOCORTICOID EXCESS; HOWEVER, OVER THE SUBSEQUENT 12 MONTHS, CLASSIC FEATURES OF CUSHING'S SYNDROME DEVELOPED INCLUDING HYPERTENSION, WEIGHT GAIN,

  Patient problems: No Code Available

  MAUDE report 9290144 ↗
• MalfunctionSep 25, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION BY THE HEAD OF SIEMENS COMMERCIAL PRODUCT QUALITY IN THE ENDOCRINE SOCIETY JOURNAL ARTICLE TITLED "ASSAY-SPECIFIC SPURIOUS ACTH RESULTS LEAD TO MISDIAGNOSIS, UNNECESSARY TESTING, AND SURGICAL MISADVENTURE - A CASE SERIES" DATED JANUARY 18, 2019 BY "LOREN WISSNER GREENE, MD, MA, FACE, FACP, ELIZA B. GEER, MD, GABRIELLE PAGE-WILSON, MD, MS, JAMES W. FINDLING, MD, FACP, HERSHEL RAFF, PHD, FAAAS, FAPS". IN ONE CASE FALSELY ELEVATED ACTH (IMMULITE) RESULTS WERE OBTAINED ON A 21 YEAR OLD FEMALE DUE TO INTERFERING ANTIBODIES, WHICH RESULTED IN SEVERAL INVASIVE DIFFERENTIAL DIAGNOSTIC PROCEDURES (INCLUDING INFERIOR PETROSAL SINUS SAMPLING), MRIS, AND UNNECESSARY PITUITARY SURGERY. ACTH RESULTS ON THE PATIENT SAMPLE TESTED ON AN ALTERNATE PLATFORM WERE NORMAL AND FURTHER STUDIES EXCLUDED THE DIAGNOSIS OF CUSHING'S SYNDROME. A 21 YEAR OLD FEMALE PRESENTED AFTER EVALUATION BY SEVERAL OTHER PHYSICIANS. SHE REPORTED A 45-50 LB. WEIGHT GAIN AFTER TAKING CLOMIPHENE ALONE OR IN COMBINATION WITH DEXAMETHASONE FOR IRREGULAR MENSES WITH INFERTILITY. SHE HAD A HISTORY OF HYPERTENSION, HEADACHES, FEVER, INSOMNIA, FATIGUE, ABDOMINAL PAIN, RASHES,

  Patient problems: No Code Available

  MAUDE report 9115532 ↗
• MalfunctionSep 25, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION BY THE HEAD OF SIEMENS COMMERCIAL PRODUCT QUALITY IN THE ENDOCRINE SOCIETY JOURNAL ARTICLE TITLED "ASSAY-SPECIFIC SPURIOUS ACTH RESULTS LEAD TO MISDIAGNOSIS, UNNECESSARY TESTING, AND SURGICAL MISADVENTURE - A CASE SERIES" DATED JANUARY 18, 2019 BY "LOREN WISSNER GREENE, MD, MA, FACE, FACP, ELIZA B. GEER, MD, GABRIELLE PAGE-WILSON, MD, MS, JAMES W. FINDLING, MD, FACP, HERSHEL RAFF, PHD, FAAAS, FAPS". IN ONE CASE FALSELY ELEVATED ACTH (IMMULITE) RESULTS WERE OBTAINED ON A 21 YEAR OLD FEMALE DUE TO INTERFERING ANTIBODIES, WHICH RESULTED IN SEVERAL INVASIVE DIFFERENTIAL DIAGNOSTIC PROCEDURES (INCLUDING INFERIOR PETROSAL SINUS SAMPLING), MRIS, AND UNNECESSARY PITUITARY SURGERY. ACTH RESULTS ON THE PATIENT SAMPLE TESTED ON AN ALTERNATE PLATFORM WERE NORMAL AND FURTHER STUDIES EXCLUDED THE DIAGNOSIS OF CUSHING'S SYNDROME. A 21 YEAR OLD FEMALE PRESENTED AFTER EVALUATION BY SEVERAL OTHER PHYSICIANS. SHE REPORTED A 45-50 LB. WEIGHT GAIN AFTER TAKING CLOMIPHENE ALONE OR IN COMBINATION WITH DEXAMETHASONE FOR IRREGULAR MENSES WITH INFERTILITY. SHE HAD A HISTORY OF HYPERTENSION, HEADACHES, FEVER, INSOMNIA, FATIGUE, ABDOMINAL PAIN, RASHES,

  Patient problems: No Code Available

  MAUDE report 9115531 ↗
• MalfunctionSep 25, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION BY THE HEAD OF SIEMENS COMMERCIAL PRODUCT QUALITY IN THE ENDOCRINE SOCIETY JOURNAL ARTICLE TITLED "ASSAY-SPECIFIC SPURIOUS ACTH RESULTS LEAD TO MISDIAGNOSIS, UNNECESSARY TESTING, AND SURGICAL MISADVENTURE - A CASE SERIES" DATED JANUARY 18, 2019 BY "LOREN WISSNER GREENE, MD, MA, FACE, FACP, ELIZA B. GEER, MD, GABRIELLE PAGE-WILSON, MD, MS, JAMES W. FINDLING, MD, FACP, HERSHEL RAFF, PHD, FAAAS, FAPS". IN ONE CASE FALSELY ELEVATED ACTH (IMMULITE) RESULTS WERE OBTAINED ON A 21 YEAR OLD FEMALE DUE TO INTERFERING ANTIBODIES, WHICH RESULTED IN SEVERAL INVASIVE DIFFERENTIAL DIAGNOSTIC PROCEDURES (INCLUDING INFERIOR PETROSAL SINUS SAMPLING), MRIS, AND UNNECESSARY PITUITARY SURGERY. ACTH RESULTS ON THE PATIENT SAMPLE TESTED ON AN ALTERNATE PLATFORM WERE NORMAL AND FURTHER STUDIES EXCLUDED THE DIAGNOSIS OF CUSHING'S SYNDROME. A 21 YEAR OLD FEMALE PRESENTED AFTER EVALUATION BY SEVERAL OTHER PHYSICIANS. SHE REPORTED A 45-50 LB. WEIGHT GAIN AFTER TAKING CLOMIPHENE ALONE OR IN COMBINATION WITH DEXAMETHASONE FOR IRREGULAR MENSES WITH INFERTILITY. SHE HAD A HISTORY OF HYPERTENSION, HEADACHES, FEVER, INSOMNIA, FATIGUE, ABDOMINAL PAIN, RASHES,

  Patient problems: No Code Available

  MAUDE report 9115529 ↗
• MalfunctionSep 25, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION BY THE HEAD OF SIEMENS COMMERCIAL PRODUCT QUALITY IN THE ENDOCRINE SOCIETY JOURNAL ARTICLE TITLED "ASSAY-SPECIFIC SPURIOUS ACTH RESULTS LEAD TO MISDIAGNOSIS, UNNECESSARY TESTING, AND SURGICAL MISADVENTURE - A CASE SERIES" DATED JANUARY 18, 2019 BY "LOREN WISSNER GREENE, MD, MA, FACE, FACP, ELIZA B. GEER, MD, GABRIELLE PAGE-WILSON, MD, MS, JAMES W. FINDLING, MD, FACP, HERSHEL RAFF, PHD, FAAAS, FAPS". IN ONE CASE FALSELY ELEVATED ACTH (IMMULITE) RESULTS WERE OBTAINED ON A (B)(6) YEAR OLD FEMALE DUE TO INTERFERING ANTIBODIES, WHICH RESULTED IN SEVERAL INVASIVE DIFFERENTIAL DIAGNOSTIC PROCEDURES (INCLUDING INFERIOR PETROSAL SINUS SAMPLING), MRIS, AND UNNECESSARY PITUITARY SURGERY. ACTH RESULTS ON THE PATIENT SAMPLE TESTED ON AN ALTERNATE PLATFORM WERE NORMAL AND FURTHER STUDIES EXCLUDED THE DIAGNOSIS OF CUSHING'S SYNDROME. A (B)(6) YEAR OLD FEMALE PRESENTED AFTER EVALUATION BY SEVERAL OTHER PHYSICIANS. SHE REPORTED A 45-50 LB. WEIGHT GAIN AFTER TAKING CLOMIPHENE ALONE OR IN COMBINATION WITH DEXAMETHASONE FOR IRREGULAR MENSES WITH INFERTILITY. SHE HAD A HISTORY OF HYPERTENSION, HEADACHES, FEVER, INSOMNIA, FATIGUE, ABDOMINAL PAIN,

  Patient problems: No Code Available

  MAUDE report 9115528 ↗
• MalfunctionSep 25, 2019High Test Results; High Test Results

  THIS MDR IS BEING FILED BASED ON REVIEW OF A PUBLICATION BY THE HEAD OF SIEMENS COMMERCIAL PRODUCT QUALITY IN THE ENDOCRINE SOCIETY JOURNAL ARTICLE TITLED "ASSAY-SPECIFIC SPURIOUS ACTH RESULTS LEAD TO MISDIAGNOSIS, UNNECESSARY TESTING, AND SURGICAL MISADVENTURE - A CASE SERIES" DATED JANUARY 18, 2019 BY "LOREN WISSNER GREENE, MD, MA, FACE, FACP, ELIZA B. GEER, MD, GABRIELLE PAGE-WILSON, MD, MS, JAMES W. FINDLING, MD, FACP, HERSHEL RAFF, PHD, FAAAS, FAPS". IN ONE CASE FALSELY ELEVATED ACTH (IMMULITE) RESULTS WERE OBTAINED ON A 21 YEAR OLD FEMALE DUE TO INTERFERING ANTIBODIES, WHICH RESULTED IN SEVERAL INVASIVE DIFFERENTIAL DIAGNOSTIC PROCEDURES (INCLUDING INFERIOR PETROSAL SINUS SAMPLING), MRIS, AND UNNECESSARY PITUITARY SURGERY. ACTH RESULTS ON THE PATIENT SAMPLE TESTED ON AN ALTERNATE PLATFORM WERE NORMAL AND FURTHER STUDIES EXCLUDED THE DIAGNOSIS OF CUSHING'S SYNDROME. A 21 YEAR OLD FEMALE PRESENTED AFTER EVALUATION BY SEVERAL OTHER PHYSICIANS. SHE REPORTED A 45-50 LB. WEIGHT GAIN AFTER TAKING CLOMIPHENE ALONE OR IN COMBINATION WITH DEXAMETHASONE FOR IRREGULAR MENSES WITH INFERTILITY. SHE HAD A HISTORY OF HYPERTENSION, HEADACHES, FEVER, INSOMNIA, FATIGUE, ABDOMINAL PAIN, RASHES,

  Patient problems: No Code Available

  MAUDE report 9115527 ↗