Access Total BhCG (5th IS) A85264Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15099590226213), received between Sep 28, 2016 and Nov 14, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Low Test Results; Low Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED OBTAINING AN ERRONEOUS LOW HCG5 (ACCESS TOTAL B- HCG, PART NUMBER A85264, LOT NUMBER 538701) PATIENT RESULT INVOLVING THE LABORATORY'S ACCESS 2 ANALYZER SERIAL NUMBER (B)(6). THE INITIAL RESULT ON (B)(6) 2025 WAS 17.34 MIU/ML. WHEN REPEATED FOUR (4) DIFFERENT TIMES ON (B)(6) 2025 THE RESULTS WERE 257.88, 261.74, 254.06 AND 267.50 (ALL MIU/ML). THE CUSTOMER REPORTED THAT THE PATIENT¿S MEDICATION WAS DISCONTINUED DUE TO THE INITIAL FALSE LOW RESULT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED ON (B)(6) 2025AND PASSED WITHIN SPECIFICATIONS. CALIBRATION PASSED ON (B)(6) 2025 WITH REAGENT LOT 538701 AND CALIBRATOR LOT 440507. OVERALL QUALITY CONTROL (QC) MATERIAL HAS BEEN PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23551795 ↗
• InjuryNov 15, 2024High Test Results; High Test Results

  ON (B)(6) 2024, THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED HCG5 RESULTS FOR ONE PATIENT (ACCESS TOTAL B- HCG) INVOLVING THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYSER (SERIAL NUMBER SN: (B)(6). THE INITIAL RESULT RECEIVED FOR THE SAMPLE WAS 55.0 MIU/ML ON (B)(6) 2024. WHEN THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT TWO DAYS LATER THE RESULT WAS 1.2 MIU/ML. THE SAMPLE WAS ALSO REPEATED ON AN ALTERNATE DXI ANALYZER, SN: (B)(6), AND THE RESULT WAS 1.1 MIU/ML. THE CUSTOMER NOTED THAT PATIENT TREATMENT CHANGED DUE TO THE FALSE HIGH RESULT. THE PATIENT¿S MEDICATION DOSAGE WAS ADJUSTED TO LOWER DUE TO THE FALSE HIGH RESULT (MEDICATION UNKNOWN). THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED BY ANY OF THE CHANGES. NO FURTHER INFORMATION WAS PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT: 439671 AND CALIBRATOR LOT: 439577. QUALITY CONTROL (QC) HAS BEEN PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20693006 ↗
• InjuryMay 21, 2024High Test Results; High Test Results

  ON (B)(6) 2024 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED HCG5 RESULTS FOR ONE PATIENT ( ACCESS TOTAL B- HCG) INVOLVING THE LABORATORY'S DXI 600 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (SERIAL NUMBER (B)(6)). THE INITIAL HCG PATIENT SAMPLE RESULT WAS 25.7 IU/L ON (B)(6) 2024 (CUSTOMER REFERENCE RANGE <5.0 IU/L). A NEW SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2024 WITH A RESULT OF 49.6 IU/L AND THIS SAMPLE WAS REPEATED THE DAY AFTER ON AN ALTERNATE DXI 800 (SERIAL NUMBER NOT PROVIDED) WITH A SIMILAR RESULT OF 45.0 IU/L. THE SAMPLE WAS RUN ON SIEMENS DIMENSION EXL INSTRUMENT WITH A DISCORDANT RESULT AT 1 IU/L (REFERENCE RANGE 0-5 IU/L). THE CUSTOMER REPORTED THAT THE PATIENT HAD SURGERY CANCELLED DUE TO THE ELEVATED ACCESS RESULTS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS CONFIRMED AS NEGATIVE (NOT PREGNANT) VIA ADDITIONAL TESTING (ULTRASOUND AND OTHER IMAGING STUDIES). NO FURTHER INFORMATION WAS PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOM

  Patient problems: Insufficient Information

  MAUDE report 19359483 ↗
• InjurySep 9, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED ERRONEOUS ELEVATED HCG (ACCESS TOTAL BHCG, 5TH IS, PART NUMBER A85264 AND LOT NUMBER 233990) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYSER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE HCG RESULT OF 5 MIU/ML WAS RELEASED FROM THE LABORATORY AS A POSITIVE RESULT. THERE WAS A REPORT OF CHANGE TO PATIENT MANAGEMENT IN CONNECTION WITH THE EVENT. THE CUSTOMER REPORTED THE PATIENT HAD A DELAY TO CHEMOTHERAPY INFUSION TREATMENT. THE REPORT OF 5 MIU/ML WAS QUESTIONED BY THE PHYSICIAN; THE LABORATORY REPEAT TESTED THE PATIENT SAMPLE ON THEIR SECOND DXI SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED A RESULT OF 35 MIU/ML. THE PATIENT WAS REDRAWN AND THE REDRAWN SAMPLE WAS TESTED ON BOTH OF THE CUSTOMER'S DXI INSTRUMENTS; RESULTS OF 1 MIU/ML OR <1 MIU/ML WERE OBTAINED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLES COLLECTED WERE SERUM SAMPLES AND LIT

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

  MAUDE report 15396940 ↗
• InjuryNov 23, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED AN ERRONEOUS NON-REPRODUCIBLE ELEVATED BHCG (ACCESS TOTAL B- HCG, PART NUMBER (B)(4) AND LOT NUMBER 124444) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER (B)(4) AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021. THE ERRONEOUS ELEVATED BHCG RESULT OF 354.31 MIU/ML WAS REPORTED TO THE ORDERING PHYSICIAN WHO QUESTIONED THE RESULT AS NOT MATCHING THE EXPECTED CLINICAL DIAGNOSIS; THE PHYSICIAN REQUESTED THE SAMPLE TO BE RETESTED FOR BHCG. THE SAMPLE WAS RETESTED ON (B)(6) 2021 ON ACCESS 2 SERIAL NUMBER (B)(4) AND AN ALTERNATE ACCESS 2, SERIAL NUMBER (B)(4) AND LOWER RESULTS (0.03 MIU/ML AND 0.05 MIU/ML, RESPECTIVELY) WERE OBTAINED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REDRAWN ON 05NOV2021 AND 07NOV2021 AND LOWER BHCG RESULTS WERE OBTAINED (RESULTS OF THESE REDRAWS WERE NOT PROVIDED FOR REVIEW). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. A WRITTEN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING CHANGE TO TREATMENT; HOWEVER, THE CUSTOMER REPORTED THEY DID NOT KNOW WHAT PATIENT TREATMENT WAS PERFORMED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS

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

  MAUDE report 12861193 ↗
• InjuryApr 9, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING FIVE (5) ERRONEOUS PATIENT RESULTS FOR TOTAL ¿HCG ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (S/N: (B)(4)). THERE WAS A CHANGE IN PATIENT TREATMENT DUE TO THE ELEVATED TOTAL ¿HCG RESULTS. THE PATIENT WAS OPERATED (UTERUS SCRAPING) ON (B)(6) 2019 BASED ON PRESENTATION OF BLEEDING, HYPERPLASIC UTERUS AND THE ELEVATED ACCESS TOTAL ¿HCG RESULT. THE PATIENT IS A POST-MENOPAUSAL (B)(6) WOMAN.

  Patient problems: No Code Available

  MAUDE report 8495473 ↗
• InjuryOct 10, 2018Low Test Results; Low Test Results

  DESCRIBE EVENT OR PROBLEM. 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 WI

  Patient problems: No Code Available

  MAUDE report 7953983 ↗
• InjurySep 12, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE LOW (NORMAL) BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM SERIAL (B)(4). THE INITIAL ACCESS TOTAL BHCG (5TH IS) RESULT OBTAINED ON (B)(6) 2017 WAS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY WHICH INDICATED THAT THE PATIENT WAS NOT PREGNANT. ON (B)(6) 2017 THE PATIENT'S SAMPLE WAS REANALYZED ON THE ORIGINAL ACCESS 2 IMMUNOASSAY SYSTEM AND A SIGNIFICANTLY HIGHER RESULT, IN A DIFFERENT GESTATIONAL CATEGORY (I.E. FOR A PREGNANT FEMALE), WAS OBTAINED. IN ADDITION, A SECOND SAMPLE WAS ALSO ANALYZED FOR ACCESS TOTAL BHCG (5TH IS) ON THE ORIGINAL ACCESS 2 IMMUNOASSAY SYSTEM THE SAME DAY ((B)(6) 2017) AND SIMILAR ELEVATED RESULTS WERE OBTAINED. THE INITIAL LOW ACCESS TOTAL BHCG (5TH IS) RESULT WAS RELEASED FROM THE LABORATORY. SUBSEQUENTLY, THERE WAS A CHANGE IN PATIENT TREATMENT/MANAGEMENT AS THE PATIENT HAD TAKEN THE FOLLOWING MEDICATIONS; DEXAMETHASONE, METAMIZOLE AND BUFFERIN COLD TABLETS PRIOR TO KNOWING THAT THEY WERE PREGNANT. SYSTEM PERFORMANCE INDICATORS SUCH AS ASSAY QUALITY CONTROL (QC), CALIBRATIONS, SYSTEM CHECKS AND PRECISION TESTI

  Patient problems: No Code Available

  MAUDE report 6858716 ↗
• MalfunctionNov 2, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE FALSE LOW HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) RESULT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR A PATIENT SAMPLE. ON (B)(6) 2016, A LOW ACCESS TOTAL BHCG (5TH IS) RESULT OF 0.06 MIU/ML WAS GENERATED AND WAS QUESTIONED AS THE RESULT DID NOT CORRELATE WITH AN ACCESS TOTAL BHCG (5TH IS) RESULT OF 795 MIU/ML THAT WAS GENERATED FOR THIS SAME PATIENT 17 HOURS AGO. THE 0.06 MIU/ML SAMPLE WAS REPEATED AND A RESULT OF 759 MIU/ML WAS GENERATED. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED WITH A RESULT OF 820 MIU/ML. RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CALIBRATION AND SYSTEM CHECK WERE PASSING ASSAY AND SYSTEM SPECIFICATIONS PRIOR TO PATIENT TESTING. THE CUSTOMER STATED THAT CONTROLS HAVE BEEN RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE SAMPLE WAS COLLECTED IN A 12X75 MM SERUM RED TOP TUBE WITH NO GEL BARRIER AND WAS CENTRIFUGED AT 3000 REVOLUTIONS PER MINUTES (RPMS) FOR 10 MINUTES. THE SAMPLE WAS RUN IN AN ALIQUOT TUBE. THE CUSTOMER NOTED THE SAMPLE WAS NORMAL IN A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6073745 ↗
• MalfunctionSep 28, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING A REPRODUCIBLE ELEVATED TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) RESULT FOR ONE (1) PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ONCE WITH THE ONBOARD DILUTION FEATURE AND ONCE WITH THE SPECIAL DILUTION FEATURE AND GENERATED ELEVATED RESULTS, ABOVE THE EXPECTED VALUES FOR THE PATIENT'S GESTATIONAL AGE. A NEW SAMPLE FROM THE SAME PATIENT WAS COLLECTED AND ANALYZED ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND A SIMILAR RESULT ABOVE THE ASSAY'S HIGHEST CALIBRATOR VALUE WAS OBTAINED. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ONCE WITH THE ONBOARD DILUTION FEATURE AND GENERATED AN ELEVATED RESULT, ABOVE THE EXPECTED VALUES FOR THE PATIENT'S GESTATIONAL AGE. THE ELEVATED ACCESS TOTAL BHCG (5TH IS) RESULT WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CALIBRATION, QC (QUALITY CONTROL) AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5983885 ↗