IMMULITE® 2000 Systems E2 Estradiol 10702833Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00630414947907), received between Nov 9, 2018 and Feb 27, 2020 — classified as 4 injuries, 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (34 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K932926); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, 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 ↗
• 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. 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 9763232 ↗
• 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 9763231 ↗
• 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 9763227 ↗
• MalfunctionFeb 27, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED IMPRECISION WHILE COMPARING PATIENT RESULTS FROM ESTRADIOL (E2) LOT 501 TO ESTRADIOL E2 LOT 405 ON IMMULITE 2000 XPI. THE CUSTOMER DID NOT REPORT ANY E2 RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT CONSIDER THE RESULTS FROM E2 LOT 501 TO BE ACCEPTABLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763130 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS REPEATED USING AN ALTERNATE NON-SIEMENS METHOD. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PROVIDED ANOTHER ELEVATED E2 PATIENT RESULT ON IMMULITE 2000 THAT WAS REPEATED USING AN ALTERNATE NON-SIEMENS METHOD AND THAT REPEAT RESULT WAS NOT PROVIDED. 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 9756284 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS REPEATED 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 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9756268 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS REPEATED 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 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9756259 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED IMPRECISION WHILE COMPARING PATIENT RESULTS FROM IMMULITE 2000 XPI ESTRADIOL (E2) LOT 504 TO AN ALTERNATE NON-SIEMENS METHOD. THE CUSTOMER DID NOT CONSIDER THE RESULTS FROM IMMULITE 2000 XPI E2 LOT 504 TO BE ACCEPTABLE. THE CUSTOMER DID NOT REPORT PATIENT SAMPLE RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753472 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING AN IMMULITE 2000 XPI. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS IN AUTOMATED SERIAL DILUTION OF THE SAME SAMPLE ON THE SAME IMMULITE 2000 XPI WERE LOWER. ADDITIONAL REPEAT RESULTS USING AN ALTERNATE NON-SIEMENS METHOD WERE CONSIDERED CORRECT AND 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 9753411 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED IMPRECISION WHILE COMPARING PATIENT RESULTS FROM ESTRADIOL (E2) LOT 508 TO ESTRADIOL E2 LOT 405 ON IMMULITE 2000 XPI. THE CUSTOMER DID NOT REPORT ANY E2 RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT CONSIDER THE RESULTS FROM E2 LOT 508 TO BE ACCEPTABLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE E2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932926. One submission often covers many models, so check the product and lot details in each record.

• Z-1243-2016 · Jan 13, 2016 · Terminated
  IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use t
• Z-1242-2016 · Jan 13, 2016 · Terminated
  IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMU