Access Inhibin A A36097Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590203047), received between Dec 27, 2017 and Apr 25, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2021Low Test Results; Low Test Results

  ON 29MARCH2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, ERRONEOUS LOW INHIBIN A (ACCESS INHIBIN A, PART NUMBER A36097 AND LOT NUMBER 922981) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, SERIAL NUMBER (B)(4)) FOR SEVERAL PATIENTS. CUSTOMER DID NOT INDICATE WHETHER THE ERRONEOUS INHIBIN A RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THE ERRONEOUS INHIBIN A RESULTS. SYSTEM PERFORMANCE INDICATORS SUCH AS CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED ISSUES WITH THE SYSTEM CHECK, PASSING SYSTEM CHECK WAS OBTAINED AFTER FAILING SYSTEM CHECK WITH NO INDICATION OF INTERVENTIONS PERFORMED BY CUSTOMER. SAMPLES WERE COLLECTED OFFSITE IN 12X75MM SERUM SEPARATOR TUBES; OTHER SAMPLE HANDLING INFORMATION SUCH AS SAMPLE CLOTTING TIME AND CENTRIFUGATION SPEED AND TIME WERE NOT PROVIDED. CUSTOMER NOTED THE SAMPLES WERE ALIQUOTED AND FROZEN FOR TRANSPORTATION AND THAWED AND TESTED UPON RECEIPT TO THE LABORATORY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11721842 ↗
• InjurySep 27, 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 7914487 ↗
• MalfunctionDec 27, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE, LOW DIMERIC INHIBIN A (ACCESS INHIBIN A) RESULTS FOR FOUR PATIENT SAMPLES ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE INITIAL RESULTS WERE LOWER THAN THE CUSTOMER EXPECTED. THE CUSTOMER WAS ANALYZING THE SAMPLES AS PART OF A MATERNAL SCREEN WHICH INCLUDED ALPHA-FETOPROTEIN (ACCESS AFP) UNCONJUGATED ESTRIOL (ACCESS UNCONJUGATED ESTRIOL) BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) AND ACCESS INHIBIN A. THE INITIAL RESULTS FROM THE FOUR ASSAYS RECOVERED BELOW THE CUSTOMER'S EXPECTATIONS FOR THE FOUR PATIENT SAMPLES. AN ADDITIONAL SEVEN PATIENT SAMPLES ANALYZED AT THE SAME TIME RECOVERED WITH INITIAL RESULTS BELOW THE CUSTOMER'S EXPECTATIONS. THE INITIAL RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH NON-REPRODUCIBLE ACCESS PATIENT RESULTS. THE PATIENTS' SAMPLES WERE REANALYZED ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND RECOVERED WITH HIGHER RESULTS, WITHIN THE CUSTOMER'S EXPECTED VALUES. CALIBRATIONS AND QUALITY CONTROL (QC) WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148746 ↗