Access Estradiol 33540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590231408), received between Mar 22, 2018 and Nov 27, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2019Low Test Results; Low Test Results

  ON (B)(6) 2019, THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE LOW ESTRADIOL (ACCESS ESTRADIOL) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4) ON (B)(6) 2019. THE SAMPLE WAS TESTED TWICE ON THE SAME ANALYZER; RESULTS OBTAINED WERE 685 PG/ML (10:18 AM) AND 657 PG/ML (11:47 AM). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE. THE BECKMAN COULTER ACCESS ESTRADIOL REFERENCE RANGE IS AS FOLLOWS: (B)(6) 2019. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT BASED ON THE RESULTS. THE PATIENT WAS ADMINISTERED OVIDREL HCG. CUSTOMER REPORTED SUBSEQUENT EGG RETRIEVAL WAS PERFORMED ON (B)(6) 2019. CUSTOMER REPORTED EGG RETRIEVAL MAY HAVE BEEN PERFORMED TOO SOON AS PHYSICIAN NOTED SOME OF PATIENT'S EGGS WERE IMPACTED. THE CUSTOMER SUBSEQUENTLY REPORTED THAT THE PATIENT IS CURRENTLY PREGNANT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PERFORMING WITHIN SPECIFICATIONS AND DID NOT INDICATE ANY ISSUES WITH THE SYSTEM. NO HARDWARE ERRORS WERE REPORTED AT THE TIME OF THE EVENT. CUSTOMER NOTED NO ISSUES WITH SAMPLE INTEGRITY. SAMPLE WAS COLLECTED IN 'GOLD TOP TUBE' AND WAS A FULL

  Patient problems: No Code Available

  MAUDE report 9386132 ↗
• InjuryMar 22, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ELEVATED ESTRADIOL (ACCESS ESTRADIOL) RESULTS FOR TWELVE PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). LATER THE SAME DAY, THE CUSTOMER REANALYZED THE PATIENTS' SAMPLES ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM AND OBTAINED LOWER RESULTS. THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE DOCTOR INFORMED THE LABORATORY TECHNICIAN THAT SOME OF THE DECISIONS WOULD HAVE BEEN DIFFERENT FOR SOME OF THESE PATIENTS DUE TO THE HIGHER ESTRADIOL RESULTS BUT ALL WOULD HAVE BEEN RELATED TO MEDICATION DOSAGES AND NOT PROCEDURES OR HARM. IT IS NOT CLEAR IF CHANGES TO MEDICATION DOSAGE ACTUALLY OCCURRED OR IF THE DOCTOR WAS SPECULATING THAT DOSAGE CHANGES WERE POSSIBLE WITH THE CHANGE IN ESTRADIOL RESULTS. THE NUMBER OF PATIENTS THAT MAY HAVE HAD A CHANGE TO TREATMENT WAS NOT PROVIDED. THE PATIENT REPORTS WERE CORRECTED TO THE LOWER RESULT THE SAME DAY. CALIBRATION AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. QUALITY CONTROL WAS STATED TO BE WITHIN THE CUSTOMER'S RANGES, BUT UPON EVALUATION LEVEL ONE AND TWO RECOV

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7361278 ↗