IMMULITE® 2000 Systems CEA 10380994Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414961118), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED RESULTS FOR THREE PATIENT SAMPLES COMPARED TO REPEAT RESULTS USING THE IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108112 ↗

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