IMMULITE® 2000 Systems CMP Carbamazepine 10381550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414961095), received between Sep 30, 2019 and Oct 30, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED CARBAMAZEPINE (CARB) RESULTS WERE OBTAINED USING IMMULITE 2000. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A FIRST REPEAT RESULT USING THE SAME IMMULITE 2000 XPI WAS ALSO CONSIDERED DISCORDANT. ADDITIONAL REPEAT RESULTS USING ALTERNATE SIEMENS AND NON-SIEMENS METHOD WERE LOWER. THE REPEAT RESULT FROM THE ALTERNATE SIEMENS METHOD (DIMENSION EXL) WAS 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 CARB RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257936 ↗
• MalfunctionSep 30, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBAMAZEPINE (CARB) RESULT WAS OBTAINED USING IMMULITE 2000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A FIRST REPEAT RESULT USING THE SAME IMMULITE 2000 XPI WAS ALSO CONSIDERED DISCORDANT. ADDITIONAL REPEAT RESULTS USING ALTERNATE NON-SIEMENS METHOD WERE LOWER. THE CUSTOMER COULD NOT REPORT A CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TSH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9137385 ↗