Access CEA 33200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590624842), received between Mar 22, 2018 and Jul 6, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “High Test Results” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED ERRONEOUS REPRODUCIBLE ELEVATED CEA (ACCESS CEA (CARCINOEMBRYONIC ANTIGEN), PART NUMBER 33200 AND LOT NUMBER 295069) WERE GENERATED FOR ONE (1) PATIENT ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2002. ON (B)(6) 2022 THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT OR MANAGEMENT OCCURRED IN CONJUNCTION WITH THE INCIDENT. THE PATIENT UNDERWENT A FIBROSCOPY AND AN ENDOSCOPY. THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR PATIENT OUTCOME. THE ORIGINAL CEA PATIENT RESULT WAS OVER RANGE (OVR FLAGGED) >994.0 G/L ON (B)(6) 2022 (9:31). IT WAS MANUALLY DILUTED AND FOLLOWING RESULTS WERE OBTAINED: 5.5 G/L AND 5.7 G/L WHEN DILUTED 1/10 ON (B)(6) 2022. ON (B)(6) 2002 THE PATIENT SAMPLE WAS TESTED FOR CEA; RESULTS OF 939.8 G/L AND 968.9 G/L WERE OBTAINED. ON (B)(6) 2022, PATIENT SAMPLE WAS TESTED AS FOLLOWS: 1.4 G/L WHEN DILUTED 1/2 AND 2841.5 G/L WHEN DILUTED AT 1/10. THE CUSTOMER¿S DILUTION WERE NOT LINEAR. THE PATIENT SAMPLE WAS ALSO TESTED FOR CEA USING THE ROCHE COBAS METHOD; RESULTS WERE LOW AT 3.4 NG/ML (<4.7 NG/ML) ON (B)(6) 2022 AND 3.1 NG/ML ON (B)(6) 2022 (SECOND SAM

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14939288 ↗
• InjuryDec 19, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT OBTAINING REPRODUCIBLE ELEVATED CARCINOEMBRYONIC ANITGEN (ACCESS CEA) RESULTS FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4). IN (B)(6) 2018 (EXACT DATE IS UNKNOWN) THE PATIENT HAD AN EXTREMELY ELEVATED ACCESS CEA RESULT, POST LUNG SURGERY (SURGERY OCCURRED IN (B)(6) 2017). THEN AGAIN IN (B)(6) 2018 (EXACT DATE IS UNKNOWN) THE SAME PATIENT HAD ANOTHER SIGNIFICANTLY ELEVATED ACCESS CEA RESULT. THE CUSTOMER NOTED THAT THE PATIENT'S OTHER TUMOR MARKERS (EXACT TESTS WERE NOT SUPPLIED) WERE ALL WITHIN THE APPROPRIATE CLINICAL RANGES. IN (B)(6) 2018 THE PATIENT UNDERWENT A PET CT (POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY) SCAN WITH CONTRAST DYE WHICH WAS DISCORDANT TO THE ACCESS CEA RESULTS OBTAINED TO DATE. ADDITIONAL ELEVATED ACCESS CEA RESULTS WERE ALSO OBTAINED IN (B)(6) 2018, (B)(6) 2019 AND (B)(6) 2019. AFTER OBTAINING ALL OF THE REPRODUCIBLE ELEVATED ACCESS CEA RESULTS THE PATIENT WENT TO TWO (2) OTHER HOSPITALS ((B)(6)) WHICH TESTED FOR CEA ON DIFFERENT METHODOLOGIES (EXACT METHODS ARE UNKNOWN). THOSE RESULTS CAME BACK WITHIN THE ASSAYS' NORMAL REFERENCE RANGES W

  Patient problems: No Code Available

  MAUDE report 9497315 ↗
• InjuryMar 22, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING AN ELEVATED CARCINOEMBRYONIC ANTIGEN (ACCESS CEA) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION TO THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (SERIAL NUMBER (B)(4)). THE RESULT WAS REPORTED OUT OF THE LABORATORY. DUE TO THE ELEVATED RESULT, THE PATIENT HAD A CAT SCAN AND A COLONOSCOPY. THE CUSTOMER REPORTED THAT THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF ADDITIONAL CHANGE TO TREATMENT. APPROXIMATELY ONE MONTH LATER ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT AND ANALYZED TWO TIMES ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM PORTION TO THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS SAMPLE RECOVERED WITH LOWER ACCESS CEA RESULTS. QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO HARDWARE ERRORS OR OTHER ASSAY ISSUES REPORTED IN CONJUNCTION WITH THIS EVENT. THE SAMPLES WERE COLLECTED IN SERUM TUBES AND CENTRIFUGED AT 3150 REVOLUTIONS PER MINUTE (RPM) FOR TEN MINUTES AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7362004 ↗