IMMULITE® 2000 Systems E2 Estradiol 10702834Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414947914), received between Feb 26, 2020 and Feb 26, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2020High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING AN ALTERNATE NON-SIEMENS METHOD. 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 9753652 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 9753643 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 9753642 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 9753638 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 9753637 ↗
• MalfunctionFeb 26, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 9753624 ↗

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-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
• 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