IMMULITE® 2000 Systems CEA 10380995Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414961125), received between Jun 2, 2023 and Jun 14, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K980855); 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125060 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125008 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124954 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124909 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124888 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124837 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124772 ↗
• MalfunctionJun 2, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050258 ↗
• MalfunctionJun 2, 2023High Test Results; High Test Results

  FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980855. One submission often covers many models, so check the product and lot details in each record.

• Z-1679-2018 · Jan 2, 2018 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi CEA