Access Unconjugated Estriol 33570Recalls & reported problems
Beckman Coulter, Inc. · The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590231187), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Low Test Results” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 26, 2020Class IITerminated
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Z-3006-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2018Low Test Results; Low Test Results
THE CUSTOMER REPORTED OBTAINING LOW REPRODUCTIVE TESTING RESULTS INCLUDING INHIBIN A (ACCESS INHIBIN A), BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)), UNCONJUGATED ESTRIOL (ACCESS UE3) AND ALPHA-FETOPROTEIN (ACCESS AFP) FOR ONE (1) PATIENT INVOLVING THE UNICEL DXI 800 ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ON THE SAME UNICEL DXI 800 ACCESS CLINICAL SYSTEM TWO (2) ADDITIONAL TIMES AND OBTAINED REPRODUCIBLE, HIGHER RESULTS. THE INITIAL LOW RESULTS WERE RELEASED FROM THE LABORATORY. THE PATIENT IN QUESTION UNDERWENT AN AMNIOCENTESIS TO RULE OUT TRISOMY 18 DUE TO THE LOW RESULTS OBTAINED. THE RESULTS OF THAT TESTING WERE NORMAL. THERE WAS NO ADDITIONAL INJURY OR REPORT OF DEATH ASSOCIATED WITH THIS INCIDENT. QUALITY CONTROL (QC) AND CALIBRATIONS WERE PERFORMING WITHIN THE ASSAY'S SPECIFICATIONS AT THE TIME OF THE INCIDENT. THERE WERE NO ERROR MESSAGES POSTED TO THE EVENT LOG AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION REGARDING THE COLLECTION OF THE PATIENT'S SAMPLE. CENTRIFUGATION TIME AND SPEED WERE NOT SUPPLIED BY THE CUSTOMER FOR THIS INCIDENT. NO ISSUES WITH SAMPLE INTEGRITY WERE R
Patient problems: No Code Available
MAUDE report 7955556 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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