Access hFSH 33520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590575236), received between Apr 17, 2019 and Apr 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “High Test Results” (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

Recent adverse event reports

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

• InjuryApr 17, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) TO REPORT OBTAINING A HIGHER THAN EXPECTED FOLLICLE STIMULATING HORMONE (ACCESS HFSH) RESULT FOR ONE FEMALE PATIENT ON THE LABORATORY¿S ACCESS 2 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). THE FIRST ACCESS HFSH RESULT QUESTIONED WAS ON (B)(6) 2019. THE CUSTOMER TOOK THE PATIENT OFF OF THEIR BIRTH-CONTROL MEDICATION AT THIS TIME. ANOTHER SAMPLE WAS COLLECTED AND TESTED FOR ACCESS HFSH AGAIN; ANOTHER HIGHER THAN EXPECTED RESULT WAS OBTAINED. THE CUSTOMER PERFORMED LINEAR DILUTIONS AND NOTED THAT THE RESULTS OBTAINED WERE NOT LINEAR SUGGESTING THAT A PATIENT-SOURCE INTERFERENT WAS PRESENT. THE PATIENT THEN HAD AN MRI (MAGNETIC RESONANCE IMAGING) OF THE HEAD PERFORMED WHICH WAS NORMAL (IT IS UNKNOWN IF CONTRAST DYE WAS USED). IN ADDITION, THE PATIENT RECEIVED TREATMENT WITH A GNRH (GONADOTROPIN-RELEASING HORMONE) ANTAGONIST, HOWEVER, THE ACCESS HFSH RESULT WAS STILL HIGHER THAN EXPECTED. ON (B)(6) 2019 A THIRD SAMPLE WAS TESTED FOR THE ACCESS HFSH ASSAY AND THE RESULT WAS SIMILAR; STILL ELEVATED. THIS SAMPLE WAS ALSO SENT TO A REFERENCE LABORATORY WHICH USED A DIFFERENT METHODOLOGY (TYPE UNKNOWN) AND PRETREATMENT WITH A BLOCKING REAGENT. THE

  Patient problems: No Code Available

  MAUDE report 8524260 ↗