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Access AFP 33211Recalls & reported problems

Beckman Coulter, Inc. · The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography. · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H628332111), received between Aug 17, 2016 and Aug 17, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 17, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ELEVATED ALPHA-FETOPROTEIN (ACCESS AFP) RESULTS FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE PATIENT SAMPLE IN QUESTION WAS INITIALLY ANALYZED FOR ACCESS AFP BETWEEN (B)(6) 2016 AND RESULTS OF 69.37 UG/L TO 73.42 UG/L WERE OBTAINED. THE INITIAL ACCESS AFP RESULT OBTAINED ON (B)(6) 2016 WAS SIGNIFICANTLY LOWER RESULTING AT 23.43 UG/L. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE THREE (3) ADDITIONAL TIMES ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2016 AND OBTAINED NON-REPRODUCIBLE RESULTS RANGING FROM 25.07 UG/L TO 106.81 UG/L. THE NON-REPRODUCIBLE ACCESS AFP RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WERE NO REPORTS OF CHANGE TO PATIENT TREATMENT OR CARE IN CONJUNCTION WITH THIS EVENT. THE ACCESS AFP ASSAY HAD BEEN CALIBRATED ON MULTIPLE OCCASSIONS THROUGHOUT THE MONTH OF (B)(6), PRIOR TO THE EVENT. THE CALIBRATIONS PASSED WITHIN ASSAY SPECIFICATIONS BUT INDICATE SOME VARIATIONS IN RELATIVE LIGHT UNIT (RLU) RECOVERY FROM CALIBRATION CURVE TO CALIBRATION CURVE. ONE LEVEL OF ACCESS AFP QC (QUALITY CONTROL) DATA WAS PROVIDED FOR THE MONTH OF (B)

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5882216 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.