IMMULITE 2000 Systems E2 EstradiolRecalls & reported problems across all models

We found 2 models of IMMULITE 2000 Systems E2 Estradiol by Siemens Healthcare Diagnostics Products Ltd in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2018 and Feb 27, 2020 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “High Test Results” (40 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

IMMULITE 2000 Systems E2 Estradiol 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. Feb 5, 2020Terminated

   Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

   Z-1514-2020 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported IMMULITE 2000 Systems E2 Estradiol problems

IMMULITE 2000 Systems E2 Estradiol models

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

• IMMULITE® 2000 Systems E2 Estradiol 10702833

  RADIOIMMUNOASSAY, ESTRADIOL
  1 recall34 reports
• IMMULITE® 2000 Systems E2 Estradiol 10702834

  RADIOIMMUNOASSAY, ESTRADIOL
  1 recall6 reports

Recent IMMULITE 2000 Systems E2 Estradiol adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763685 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  TWO ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLE WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763264 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  TWO ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI, THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE CUSTOMER DID NOT PROVIDE ANY REPEAT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763260 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  SIX DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. FIVE SAMPLES WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763258 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THREE ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI, THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE CUSTOMER DID NOT PROVIDE ANY REPEAT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763257 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  ONE ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE.. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE CUSTOMER DID NOT PROVIDE A REPEAT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763256 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THREE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763254 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THREE ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI, THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763252 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIALS RESULT WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. ONE SAMPLE WAS REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763250 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THREE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763247 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  ONE ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI, THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. AN ADDITIONAL REPEAT RESULT WAS OBTAINED USING AN ALTERNATE NON-SIEMENS METHOD. THE ADDITIONAL REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763246 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  FOUR ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI, THAT DID NOT REFLECT THE PATIENTS CLINICAL PICTURE. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. ONE SAMPLE WAS REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. TWO SAMPLES WERE REPEATED USING AN ALTERNATE NON-SIEMENS METHOD. THE ADDITIONAL REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763242 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. ONE SAMPLE WAS REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. ADDITIONAL REPEAT RESULTS WERE OBTAINED USING AN ALTERNATE NON-SIEMENS METHOD. THE ADDITIONAL REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763241 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THREE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED USING AN ALTERNATE IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763238 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A REPEAT RESULT WAS OBTAINED USING AN ALTERNATE NON-SIEMENS METHOD. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763234 ↗

Other Siemens Healthcare Diagnostics Products Ltd products

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