Access Progesterone 33550Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15099590231378), received between Jun 6, 2019 and Nov 21, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “High Test Results” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025High Test Results; High Test Results

  ON (B)(6) 2025, THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE FALSE ELEVATED PROGESTERONE (ACCESS PROGESTERONE REAGENT PART NUMBER 33550, LOT NUMBER 538591) PATIENT RESULTS ON THEIR ACCESS 2 ANALYZER SERIAL NUMBER (SN) (B)(6). A CHANGE TO PATIENT TREATMENT/MANAGEMENT WAS REPORTED IN CONNECTION WITH THIS EVENT. ONE PATIENT HAD HER INFERTILITY CYCLE CANCELLED AS A RESULT OF THE INITIAL ELEVATED RESULT. THE SAMPLE PATIENT PROGESTERONE RESULTS WERE AT 1.21 NG/DL, REPEATED AT 1.28 NG/ML ON (B)(6) 2025. THE RESULTS WERE QUESTIONED BY PHYSICIANS AS HIGHER THAN THE PATIENT CLINICAL PICTURE. THE SAME SAMPLE WAS RETESTED AT THE MAIN/REFERENCE LAB AT <0.5 NG/DL (UNKNOWN METHOD). NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PERFORMED ON (B)(6) 2025 AND PASSED WITHIN SPECIFICATIONS. QUALITY CONTROL (QC) MATERIAL HAS BEEN PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE IS COLLECTED IN 5ML SST GOLD TOP TUBE, RUN FRESH AND CENTRIFUGED AT 2900 RPM FOR 15 MINS AT ROOM TEMPERATURE. SAMPLE WAS TRANSPORTED TO THE REFERENCE LAB APPROXIMATELY 3 HOURS LATER IN A COOLER.

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

  MAUDE report 23618513 ↗
• InjuryApr 24, 2025High Test Results; High Test Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED PROGESTERONE PATIENTS' RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(6). DUE TO FALSE HIGH ACCESS RESULTS, THE EMBRYO TRANSFER FOR THE IVF (INVITRO FERTILIZATION) PROCEDURE WAS CANCELLED FOR ONE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT THEY QUESTIONED PROGESTERONE RESULTS THAT WERE GREATER THAN 2 NG/ML WHILE THE CLINICAL EXPECTED RESULTS SHOULD BE CLOSE TO 0 NG/ML. NO SPECIFIC DATA FOR THIS PATIENT WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER SENT OUT THE SAMPLES TO ANOTHER LABORATORY AND THE RESULTS CAME BACK AROUND 0.6 NG/ML. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECKS PASSED ON 14MAR2025,22MAR2025 AND 31MAR2025. CALIBRATION COMPLETED ON 25MAR2025 AND 14MAR2025 WITH REAGENT LOT WITH 440455 AND CALIBRATOR LOT 440099 PASSED. QUALITY CONTROLS (QC) WERE PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES AT THE TIME OF THE EVENT. WEEKLY MAINTENANCE IS PERFORMED NORMALLY ON FRIDAYS. PRECISION RUN PASSED WITH A 3.88 % CV WITHIN IMPRECISION CLAIM OF TOTAL IMPRECISION LESS T

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

  MAUDE report 21900202 ↗
• InjurySep 22, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE ELEVATED PROGESTERONE (ACCESS PROGESTERONE) RESULTS FOR ONE PATIENT UNDER IVF (IN VITRO FERTILIZATION) TREATMENT AND INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, UNEXPECTED HIGH PROGESTERONE RESULTS OF 2 NG/ML AND 1.92 NG/ML WERE GENERATED FOR ONE PATIENT SAMPLE, BOTH RESULTS WERE BEYOND THE VALUE OF 1.5 NG/ML THAT IS THE MINIMUM CUSTOMER VALUE TO PERFORM THE COLLECTION OF THE MATURE EGGS FROM OVARIES. BASED ON THESE ACCESS HIGH RESULTS, THE COLLECTION OF THE MATURE EGGS FROM OVARIES WAS FINALLY PERFORMED. UNFORTUNATELY, THE EGGS MATURITY WAS INSUFFICIENT. THE PATIENT SAMPLE WAS RETESTED ON A THIRD PLATFORM (NO FURTHER INFORMATION WAS PROVIDED) WITH AN ACCEPTABLE LOWER PROGESTERONE RESULT OF 0.89 NG/ML WHICH WAS ACCORDANT WITH THE CONCLUSION OF EGGS IMMATURITY AND DISCORDANT WITH THE BEC RESULTS. THERE WAS AN INCORRECT MANAGEMENT TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT AS THE COLLECTION OF THE MATURE EGGS FROM OVARIES SHOULD NOT HAVE BEEN PERFORMED. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. T

  Patient problems: Insufficient Information

  MAUDE report 12511634 ↗
• InjuryJul 15, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ERRONEOUS ELEVATED PROGESTERONE (ACCESS PROGESTERONE, PART NUMBER 33550, LOT NUMBER 922679) RESULTS, GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021. THE ELEVATED PROGESTERONE RESULT OF 9.217 NG/ML WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEAT TESTED TWICE ON THE SAME ACCESS 2 INSTRUMENT LATER THE SAME DAY AND RESULTS OF 0.274 NG/ML AND 0.300 NG/ML WERE OBTAINED. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER PROVIDED INFORMATION SUGGESTING A CRYO CYCLE WAS DELAYED, IMPACTING FROZEN EMBRYO TRANSFER. NO FURTHER INFORMATION WAS PROVIDED WITH REGARD TO CHANGE TO PATIENT TREATMENT OR OUTCOME. 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 PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE WAS A BD [BECTON DICKINSON SST [SERUM SEPARATOR] TUBE. SAMPLE APPEARED TO BE NORMAL. SAMPLE WAS CENTRIFUGED AT 3300 (UNITS NOT PROVIDED) FOR

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

  MAUDE report 12173989 ↗
• InjuryJun 18, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE ELEVATED PROGESTERONE (ACCESS PROGESTERONE) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, AN UNEXPECTED PROGESTERONE RESULT OF 2.34 NG/ML WAS GENERATED FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RUN THE DAY AFTER ON AN ALTERNATE METHODOLOGY (ROCHE ELECSYS) AND A LOW PROGESTERONE RESULT OF <0.1 NG/ML WAS OBTAINED (ROCHE PROGESTERONE REFERENCE RANGE IS 0.1-0.9 NG/ML). THE PATIENT WAS REDRAW AND RETESTED ON (B)(6) 2021 WITH A PROGESTERONE RESULT OF 2.09 NG/ML. THE SAMPLE WAS RUN THE SAME DAY ON AN ALTERNATE METHODOLOGY (METHODOLOGY UNKNOWN) AND A LOW RESULT OF 0.67 NG/ML WAS OBTAINED. THE CUSTOMER REPORTED THE PROGESTERONE RESULTS RUN ON ALTERNATE METHODOLOGIES ALIGNED WITH THE CLINICAL PRESENTATION OF THE PATIENT. DUE TO THE ABNORMALLY HIGH RESULTS, THE PATIENT HAS HAD THEIR IVF CYCLE CANCELLED TWICE. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS BOTH IVF CYCLE CANCELLED. MEDWATCH NUMBER ¿2122870-2021-00088¿ WILL ADDRESS THE IVF CYCLE CANCELLED ON (B)(6) 2021. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE

  Patient problems: Insufficient Information

  MAUDE report 12023759 ↗
• InjuryJun 18, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE ELEVATED PROGESTERONE (ACCESS PROGESTERONE) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, AN UNEXPECTED PROGESTERONE RESULT OF 2.34 NG/ML WAS GENERATED FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RUN THE DAY AFTER ON AN ALTERNATE METHODOLOGY (ROCHE ELECSYS) AND A LOW PROGESTERONE RESULT OF <0.1 NG/ML WAS OBTAINED (ROCHE PROGESTERONE REFERENCE RANGE IS 0.1-0.9 NG/ML). THE PATIENT WAS REDRAW AND RETESTED ON (B)(6) 2021 WITH A PROGESTERONE RESULT OF 2.09 NG/ML. THE SAMPLE WAS RUN THE SAME DAY ON AN ALTERNATE METHODOLOGY (METHODOLOGY UNKNOWN) AND A LOW RESULT OF 0.67 NG/ML WAS OBTAINED. THE CUSTOMER REPORTED THE PROGESTERONE RESULTS RUN ON ALTERNATE METHODOLOGIES ALIGNED WITH THE CLINICAL PRESENTATION OF THE PATIENT. DUE TO THE ABNORMALLY HIGH RESULTS, THE PATIENT HAS HAD THEIR IVF CYCLE CANCELLED TWICE. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS BOTH IVF CYCLE CANCELLED. MEDWATCH NUMBER ¿2122870-2021-00089¿ WILL ADDRESS THE IVF CYCLE CANCELLED ON (B)(6) 2021. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE

  Patient problems: Insufficient Information

  MAUDE report 12023758 ↗
• InjuryJun 17, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ERRONEOUS ELEVATED PROGESTERONE (ACCESS PROGESTERONE, PART NUMBER 33550, LOT NUMBER 922679) RESULTS, GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(6)) ON 19APRIL2021. THE ELEVATED PROGESTERONE RESULT OF 3.682 NG/ML WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEAT TESTED ON THE SAME ACCESS 2 INSTRUMENT LATER THE SAME DAY AND A RESULT OF 0.679 NG/ML WAS OBTAINED.

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

  MAUDE report 12017262 ↗
• InjuryJun 17, 2021High Test Results; High Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ERRONEOUS ELEVATED PROGESTERONE (ACCESS PROGESTERONE, PART NUMBER 33550, LOT NUMBER 922679) RESULTS, GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(6)) ON (B)(6) 2021. THE ELEVATED PROGESTERONE RESULT OF 2.076 NG/ML WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEAT TESTED ON THE SAME ACCESS 2 INSTRUMENT LATER THE SAME DAY AND A RESULT OF 0.430 NG/ML WAS OBTAINED.

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

  MAUDE report 12017247 ↗
• InjuryJun 8, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED QUESTIONING A HIGH PROGESTERONE RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, A PATIENT SAMPLE WAS TESTED WITH ONE UNEXPECTED HIGH PROGESTERONE RESULT OF 5.76 NG/ML. THE CUSTOMER REPORTED THAT THE PATIENT WAS WAITING FOR AN OVULATION INDUCTION AND THE DOCTOR EXPECTED A LOW PROGESTERONE RESULT (THE PROGESTERONE RESULT SHOULD BE < 1 NG/ML). MOREOVER, PREVIOUSLY ON (B)(6) 2021 THE PROGESTERONE PATIENT RESULT WAS AT 0.19 NG/ML. THE PATIENT WAS REDRAW THE SAME DAY AND THE NEW SAMPLE WAS RETESTED WITH A SIMILAR PROGESTERONE RESULT OF 7.7 NG/ML WHICH PRECLUDED THE POSSIBILITY OF OVULATION INDUCTION. ON (B)(6) 2021, THE SAMPLE WAS RETESTED ON THE ROCHE PLATFORM WITH A SIMILAR HIGH RESULT OF 6.02 NG/ML. THE CUSTOMER CANCELED THE OVULATION INDUCTION AND DELAYED THE TREATMENT TO NEXT PHYSIOLOGICAL CYCLE. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. CALIBRATION PASSED ON 30APR2021 WITH REAGENT LOT 922125 AND CALIBRATOR LOT 922326. NO SYSTEM CHECK WAS PROVIDED. A BECKMAN LA

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

  MAUDE report 11958456 ↗
• InjuryAug 27, 2020High Test Results; High Test Results

  ON (B)(6) THE CUSTOMER REPORTED AN ERRONEOUS ELEVATED ACCESS PROGESTERONE RESULT (PART NUMBER 335550 AND LOT NUMBER 921789) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) (PATIENT RESULT NOT PROVIDED). THE ERRONEOUS ELEVATED ACCESS PROGESTERONE RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT DUE TO THE ELEVATED PROGESTERONE RESULT, THE INTRAUTERINE INSEMINATION (IUI) PROCEDURE SCHEDULED FOR THE PATIENT WAS DELAYED (LENGTH OF DELAY OF PROCEDURE NOT PROVIDED). THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING PATIENT TREATMENT OR MANAGEMENT. ALTHOUGH THE CUSTOMER REPORTED THEIR QUALITY CONTROL LEVEL 2 WAS OUT OF RANGE AT THE TIME OF THE EVENT, OTHER SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; THERE WAS NO REPORT OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN A BECTON DICKINSON (BD) 8 ML SERUM SEPARATOR TUBE (SST) AND WAS NOTED TO BE A CLEAN SAMPLE. CUSTOMER STATED SAMPLE WAS CENTRIFUGED F

  Patient problems: No Code Available

  MAUDE report 10463115 ↗
• InjuryJun 6, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED PROGESTERONE PATIENT RESULTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (S/N: (B)(4)). THE CUSTOMERS PATIENT RESULTS WERE HIGHER THAN THE NORMAL RANGE OF THE ASSAY. RESULTS WERE ALSO DISCORDANT WITH THE ROCHE METHOD. NO FURTHER INFORMATION WAS PROVIDED ON THE ROCHE METHOD. THERE WAS A CHANGE IN PATIENT TREATMENT. SOME PATIENTS (NUMBER UNKNOWN) WERE TREATED BASED UPON THE ELEVATED ACCESS PROGESTERONE RESULTS. GNRH ANTAGONIST WAS GIVEN TO THOSE PATIENTS UNDER IVF PROCEDURE TO LOWER THEIR PROGESTERONE LEVEL. THE DURATION OF THE TREATMENT VARIED BETWEEN 10-15 DAYS AND THE EMBRYO TRANSFER MAY BE ONE MONTH DELAYED. THERE WAS NO FURTHER REPORT OF CHANGE TO TREATMENT NOR ANY OTHER ADVERSE EFFECT REPORTED.

  Patient problems: No Code Available

  MAUDE report 8674230 ↗