IMMULITE® 2000 Systems CVG CMV IgG 10381309Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414961231), received between Mar 19, 2018 and Dec 29, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 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.

• MalfunctionDec 29, 2025False Negative Result; False Negative Result

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT A FALSE NEGATIVE CYTOMEGALOVIRUS IGG (CMV IGG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 CMV IGG REAGENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A FROZEN ALIQUOT OF THE SAME SAMPLE WAS RERUN FOR CMV IGG ON (B(6) 2025, RECOVERING POSITIVE. THE POSITIVE RESULT WAS CONFIRMED ON A NON-SIEMENS ANALYZER. THE SAMPLE WAS RECOLLECTED ON (B)(6) 2025 AND RETURNED ANOTHER POSITIVE RESULT. THE POSITIVE 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 ERRONEOUS CMV IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23912744 ↗
• MalfunctionSep 14, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT FOR A PATIENT IN (B)(6) 2022. THE PATIENT WAS TESTED AGAIN IN (B)(6) 2022 ON THE ATELLICA IM CMV IGG AND THE RESULT WAS POSITIVE. THE CUSTOMER THEN TESTED A SAMPLE ON THE ATELLICA IM CMV IGG ASSAY FROM THIS PATIENT THAT WAS DRAWN IN 2019 AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE ATELLICA IM CMV IGG RESULTS, THE CUSTOMER ASSUMES THAT THE NEGATIVE IMMULITE 2000 XPI CMV IGG RESULT IS DISCORDANT. IT IS UNKNOWN IF THE NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NEGATIVE CMV IGG PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422835 ↗
• MalfunctionJun 24, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A FALSE-POSITIVE IMMULITE 2000 CMV IGG (CVG) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND REPEAT TESTING. AN INITIAL NEGATIVE CVG RESULT WAS OBTAINED FOR THIS PATIENT ON (B)(6) 2022, AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT, AND REPEAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT, PRODUCING A POSITIVE RESULT WHICH WAS ACCEPTED AS CORRECT. THE NEGATIVE CVG RESULT WAS NOT CONSISTENT WITH POSITIVE INDICATIONS FROM OTHER TESTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NEGATIVE CMV IGG PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806073 ↗
• MalfunctionJun 3, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED INITIAL, NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULTS FOR FOUR PATIENTS THAT WERE POSITIVE UPON REPEAT TESTING ON THE SAME IMMULITE 2000 XPI . THE PATIENTS WERE EXPECTED TO BE POSITIVE BASED ON HISTORICAL DATA. ONE SAMPLE WAS ALSO POSITIVE ON TWO ALTERNATE METHODS. PREVIOUS NUMERIC RESULTS WERE NOT PROVIDED. THE NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NEGATIVE CMV IGG PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598491 ↗
• MalfunctionMay 25, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A NONREACTIVE (NEGATIVE) IMMULITE 2000 XPI CMV IGG (CVG) RESULT FOR A PATIENT SAMPLE ON (B)(6) 2022 THAT WAS CONSIDERED DISCORDANT WITH THE PREVIOUS RESULT FROM ON (B)(6) 2022. THE SAMPLE WAS REPEATED ON THE IMMULITE 2000 XPI CMV IGG (CVG) ASSAY ON (B)(6) 2022 AND THE RESULT WAS REACTIVE (POSITIVE). THE DISCORDANT NONREACTIVE (NEGATIVE) RESULT WAS NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NONREACTIVE (NEGATIVE) IMMULITE 2000 XPI CMV IGG (CVG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495243 ↗
• MalfunctionMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, (B)(6) RESULT FOR IGG ANTIBODIES TO (B)(6) ASSAY WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 328. THE (B)(6) RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS INITIALLY RUN USING KIT LOTS 326 AND 327, RESULTING INDETERMINATE AND (B)(6) RESPECTIVELY. THE CUSTOMER REPORTED AN INDETERMINATE RESULT FROM KIT LOT 326 AND CONSIDERED IT TO BE CORRECT. THE (B)(6) RESULT OBTAINED USING KIT LOT 327 WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7349099 ↗