Access GI Monitor 387687Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590231842), received between Jul 19, 2022 and Feb 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “High Test Results” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K033038); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THE PATIENT WAS ORDERED IMAGING TESTS BECAUSE OF THE HIGH ACCESS GI MONITOR RESULT. ON (B)(6)2023, THE CUSTOMER DID INDICATE THAT THE IMAGING TESTS WERE PET (POSITRON EMISSION TOMOGRAPHY) SCAN (FDG 1 -F) AND TOMOGRAPHY WITHOUT CONTRAST THAT HAVE DEMONSTRATED A DECREASE IN LESION. NO ADDITIONAL IMPACT TO THE PATIENT WAS REPORTED IN CONNECTION WITH THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16348868 ↗
• InjuryJul 19, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FALSE ELEVATED ACCESS GI MONITOR (CA 19-9) (LOT NUMBER 125013) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4). THE EXACT NUMBER OF PATIENTS INVOLVED IN THIS EVENT WAS NOT SPECIFIED. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, MULTIPLE PATIENTS SAMPLES RESULTS WERE AROUND 200 U/ML (AROUND LAST TWENTY TESTS OF THE REAGENT PACK 8600). THE ELEVATED PATIENT SAMPLES WERE RECHECKED WITH LOWER RESULTS. (NO DATA PROVIDED). THE CUSTOMER ALSO RECHECKED OTHER SAMPLES TESTED WITH DIFFERENT REAGENT PACKS BEFORE AND AFTER THE QUESTIONED ONE. THE RESULTS WERE AS EXPECTED. THE EXPECTED VALUES FOR THE GI MONITOR (CA 19.9) ASSAY ARE < 35 U/ML. THE CUSTOMER REPORTED SOME PATIENTS WERE ORDERED A CONTRAST ENHANCED COMPUTED TOMOGRAPHY BECAUSE OF THE HIGH ACCESS GI MONITOR RESULTS. NO ADDITIONAL IMPACT OR CHANGE TO PATIENT TREATMENT WAS REPORTED IN CONNECTION WITH THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON 6JUL2022. CALIBRATION PASSED ON 7JUL2022 USING REAGENT LOT 125013 AND CALIBRATOR LOT 124563. QUALITY CONTROL

  Patient problems: Insufficient Information

  MAUDE report 15049658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033038. One submission often covers many models, so check the product and lot details in each record.

• Z-2241-2020 · Apr 30, 2019 · Terminated
  Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2,
• Z-2638-2017 · May 9, 2017 · Terminated
  Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687