Elecsys CEA Assay 4491777160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630938919), received between Dec 19, 2022 and May 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionMay 5, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CEA ASSAY, AND SEVERAL OTHER ASSAY RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 (UL) V, WITH SERIAL NUMBER (B)(4). THE REPORTER STATED, THAT THE QC WAS OUT OF RANGE AND MULTIPLE PATIENT RESULTS WERE FLAGGED. THE REPORTER THEN RAN AN ASSAY PROFILE OF THE EVENING SHIFT AND NOTED, THAT THE QC FOR CEA WAS OUT OF RANGE TWICE. THE PROCELL AND CLEANCELL WERE THEN REPLACED. THE QC WAS RERUN WITH ACCEPTABLE RESULTS. THE REPORTER PULLED AN INTERFACE REPORT AND NOTICED SEVERAL LOW RESULTS ON MULTIPLE ASSAYS. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF QUESTIONABLE RESULTS. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 1: ON (B)(6) 2023, THE INITIAL RESULT USING AN ALIQUOTED SAMPLE WAS 63.46 NG/ML. ON (B)(6) 2023, THE REPEAT RESULT USING THE PRIMARY TUBE (AFTER SERVICE) WAS 118.9 NG/ML. SAMPLE 2: THE INITIAL RESULT WAS 0.5 NG/ML. THE REPEAT RESULT WAS 5.66 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877246 ↗
• MalfunctionDec 19, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CEA ELECSYS RESULT FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.97 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE QC PERFORMED AFTERWARD WAS NOT ACCEPTABLE. THE CUSTOMER RECALIBRATED THE ASSAY AND RAN QC WHICH WAS ACCEPTABLE. THE CUSTOMER THEN REPEATED THE SAMPLE. THE REPEAT RESULT WAS 1.54 NG/ML AND WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004402 ↗