AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900Recalls & reported problems

Summary

The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 04560189283992), received between Mar 13, 2018 and Sep 17, 2026 — classified as 381 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (201 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 381 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Mechanical Problem

  A customer reported the "sorter door will not close" on the AIA-900 analyzer. The customer stated some test cups fell into the sorter and were obstructing the door. The customer is unable to clear the obstruction. The analyzer is down.A Field Service Engineer (FSE) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for Creatine Kinase MB Isoenzyme (CK-MB) and Cardiac Troponin I (cTnl 2). There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797400 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  A customer reported error ¿4124 Sample-Z bump¿ on the AIA-900 analyzer. Prior to calling Technical Support Specialist (TSS), the customer identified multiple tips jammed into the well and cleared the tips. The customer restarted the analyzer and is also receiving errors 4313 Wash1-Z home overrun, 4323 Wash2-Z home overrun, 4193 S.loader-X3 home overrun, 4173 S.loader-X1 home overrun, and 4183 S.loader-X2 home overrun. The analyzer is down.A Field Service Engineer (FSE) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for Progesterone (PROG III). There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797385 ↗
• MalfunctionSep 15, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782316 ↗
• MalfunctionAug 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268629 ↗
• MalfunctionAug 4, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136557 ↗
• MalfunctionJul 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101318 ↗
• MalfunctionJul 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094071 ↗
• MalfunctionMay 26, 2026Calibration Problem

  A CUSTOMER REPORTED THAT CALIBRATION DID NOT PASS FOR PROGESTERONE (PROG III). THE CUSTOMER DID NOT HAVE ANY REMAINING CALIBRATOR SETS FOR PROG III TO RECALIBRATE AND IT IS CURRENTLY BACKORDERED. A TECHNICAL SUPPORT SPECIALIST (TSS) SENT THE CUSTOMER PROG II TO USE UNTIL PROG III IS BACK IN STOCK. TSS FOLLOWED UP WITH THE CUSTOMER AND ENSURED THEY ARE ABLE TO RUN PROG II WITHOUT ISSUES. THE CUSTOMER IS WAITING FOR PROG III TO ARRIVE WHICH HAS RESULTED IN A DELAY. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295415 ↗
• MalfunctionMay 15, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE¿ 3004 LIQUID LEAK DETECTED¿ ON THE AIA-900 ANALYZER. THE CUSTOMER VISUALLY INSPECTED THE BF PROBE AREA AND IDENTIFIED EXCESS LIQUID AND ONE OF THE WELLS WAS NOT DRAINING PROPERLY. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO POWER OFF THE ANALYZER. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAY REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND PROGESTERONE (PROG III). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194663 ↗
• MalfunctionMay 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED TWO DISCREPANT RESULTS FOR ESTRADIOL (E2) ON THE AIA-900 ANALYZER. SAMPLE #1 WAS REPORTED OUT WITH A RESULT OF 600 PG/ML. PROVIDERS QUESTIONED THE RESULT, RERAN THE SAMPLE AND RECEIVED A NEW RESULT OF 25 PG/ML, WHICH WAS THE EXPECTED VALUE. SAMPLE #2 WAS REPORTED OUT AS LESS THAN LOW (<L). PROVIDERS AGAIN QUESTIONED THE RESULT AND RERAN WITH A RESULT OF 200 PG/ML, WHICH WAS THE EXPECTED VALUE. QUALITY CONTROL (QC) WAS WITHIN RANGE AND THERE WERE NO CLOTS OR FIBRIN NOTED IN THE DISCREPANT SAMPLES. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO RECALIBRATE E2, RESOLVING THE ISSUE. THE DISCREPANT SAMPLES WERE NOT RETESTED AFTER RECALIBRATION WAS COMPLETED. THE CUSTOMER FOLLOWED UP AT A LATER DATE STATING THAT THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED AFTER RECALIBRATING. NO FURTHER ACTIONS REQUIRED FROM TOSOH. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145143 ↗
• MalfunctionMay 5, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ERROR MESSAGE "2205 SORTER DROPPED CUP" AND "DISCREPANT ESTRADIOL (E2) RESULTS" ON THE AIA-900 ANALYZER. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO PERFORM AN ALL-SET-HOME AND CONFIRM THERE ARE NO FALLEN TEST CUPS; THE ALL SET HOME CLEARED THE 2205 ERROR. THE CUSTOMER THEN REPORTED A DISCREPANT RESULT FOR E2. THE SAMPLE WAS DRAWN ONSITE THE PREVIOUS DAY AND A RESULT OF 96.5 PG/ML WAS RECEIVED. THE RESULT WAS REPORTED TO THE PROVIDER, AND QUESTIONED BY THE NURSES WHO REQUESTED THAT THE SAMPLE BE RERUN. THE SAMPLE WAS RERUN THREE HOURS LATER AND A RESULT OF 297.2 PG/ML WAS RECEIVED. QUALITY CONTROL (QC) WAS WITHIN RANGE, THERE WERE NO DELTA CHECKS (USED TO IDENTIFY SIGNIFICANT CHANGES IN LABORATORY TEST RESULTS BETWEEN CONSECUTIVE MEASUREMENTS FOR THE SAME PATIENT) AND NO FIBRIN CLOTS WERE OBSERVED IN THE SPECIMEN. THE CUSTOMER STATED THAT THE TIGER TOP TUBE WAS ALLOWED TO SIT FOR 30 MINUTES PRIOR TO CENTRIFUGING. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), PROGESTERONE (PROG III), FOLLICLE STIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083972 ↗
• MalfunctionApr 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED AMERICAN ASSOCIATION OF BIOANALYSTS-MEDICAL LABORATORY EVALUATION (AAB-MLE) M1 FEBRUARY 2026 PROFICIENCY TESTING FAILED FOR THYROID STIMULATING HORMONE (TSH) AND PROGESTERONE (PROG II) ON THE AIA-900 ANALYZER. THE TOSOH QUALITY ASSURANCE (QA) LABORATORY PASSED ALL AAB-MLE M1 FEBRUARY 2026 PROFICIENCY TESTING. THE CUSTOMER NOTED THAT THEY HAVE EXPERIENCED HIGH SUBSTRATE BACKGROUND; PER AIA-900 OPERATOR'S MANUAL, HIGH SUBSTRATE BACKGROUND COULD BE DUE TO CONTAMINATION. THE CUSTOMER PERFORMED A DECONTAMINATION FOLLOWED BY A RECALIBRATION AND QUALITY CONTROL (QC), WHICH LOWERED THE SUBSTRATE BACKGROUND. THE CUSTOMER WAS UNABLE TO PERFORM A COMPARISON STUDY BECAUSE THE PATIENT SAMPLES HAD BEEN IN THE REFRIGERATOR FOR OVER A WEEK. THE CUSTOMER STATED THAT QC AND PROFICIENCY RESULTS PASSED FOLLOWING THE MAINTENANCE THAT WAS PERFORMED. THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021714 ↗
• MalfunctionApr 13, 2026Mechanical Problem

  A CUSTOMER REPORTED "4276 INCUBATOR POSITIONING ERROR AND NOISE" ON THE AIA-900 ANALYZER. THE ISSUE OCCURRED AT THE START OF A CALIBRATION RUN AND THE CUSTOMER RESET THE POWER, BUT THE ISSUE REMAINS. AN ALL-SET-HOME WAS PERFORMED AND FAILED. IN ADDITION, A NOISE WAS HEARD WHILE ATTEMPTING TO PERFORM THE ALL-SET-HOME. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR PROGESTERONE (PROG III) AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860932 ↗
• MalfunctionApr 10, 2026Mechanical Problem

  A CUSTOMER REPORTED THE BF PROBE 1 TIP WILL NOT GO ON AND 2231 B/F PROBE 1 OVERFLOW SENSOR FAILURE ERROR ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THE LAST FEW TIMES OF PERFORMING MAINTENANCE, THERE WAS BUILD-UP FOUND ON THE PROBE TIPS. THE CUSTOMER IS UNABLE TO REPLACED THE PROBE TIP. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND PROGESTERONE (PROG III). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841787 ↗
• MalfunctionApr 2, 2026High Test Results

  A CUSTOMER REPORTED POTENTIAL DISCREPANT RESULTS FOR PROGESTERONE III (PROG III) ON THE AIA-900 ANALYZER. THE CUSTOMER REPORTED RECEIVING AN INITIAL VALUE OF 0.63NG/ML (ACCEPTABLE RANGE: 0.1 - 40NG/ML), WHICH WAS NOT THE RESULT EXPECTED PER THE PATIENT HISTORY. THE CUSTOMER VERIFIED THAT BOTH THE DAILY CHECK ON THE SUBSTRATE AND QUALITY CONTROL (QC) PASSED. THE CUSTOMER RAN ALCOHOL THROUGH THE SUBSTRATE LINES, DUE TO SUSPECTING POTENTIAL CONTAMINATION OF THE LINE, IN THE PROCESS OBSERVED THAT THE BOTTLE OF SUBSTRATE WAS LOW. A TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INSTALL A NEW SUBSTRATE SOLUTION BOTTLE AND TO RERUN SAMPLES. THE ANALYZER IS DOWN. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772253 ↗
• MalfunctionMar 30, 2026Device Ingredient or Reagent Problem

  A CUSTOMER REPORTED TESTOSTERONE LEVEL 1 QUALITY CONTROL (QC) RUNNING LOW OUT OF RANGE, AND LEVEL 2 QC RUNNING ON LOW END OF RANGE ON THE AIA-900 ANALYZER. THE CUSTOMER IS RUNNING SAMPLES USING TESTOSTERONE TEST CUP LOT F4124C2 AND BIO-RAD QC LOT 40481 (LEVEL 1) AND 40482 (LEVEL 2). TECHNICAL SUPPORT SPECIALIST (TSS) SENT THE CUSTOMER NEW LOT OF TEST CUPS, CALIBRATIONS, AND MAC CONTROLS FOR TESTING. THE ANALYZER IS DOWN. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724244 ↗
• MalfunctionMar 24, 2026Mechanical Problem; Noise, Audible

  A CUSTOMER REPORTED 4231 REAG/TIP-X HOME DETECT ERROR AND AUDIBLE NOISE ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THE ERROR OCCURS IN THE MIDDLE OF A RUN. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO VISUALLY INSPECT THE REAGENT TIP TRAY AND RESEAT IT, THEN PERFORM AN ALL-SET HOME. THE CUSTOMER CHOSE NOT TO TROUBLESHOOT AND REQUESTED SERVICE. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR PROGESTERONE (PROG III). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679151 ↗
• MalfunctionMar 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) ON THE AIA-900 ANALYZER. THE CUSTOMER STATED INITIAL RUN, RESULTED IN HIGH PATIENT RESULT. FOLLOWING THEIR LABORATORY PROTOCOL, THE CUSTOMER PERFORMED A 1:50 DILUTION AND THE PATIENT RESULT REMAINED HIGH. THE CUSTOMER THEN PERFORMED A 1:100 DILUTION, AND THE PATIENT RESULT WAS 2335.4MIU/ML. THE PATIENT NURSE REVIEWED THE RESULTS AND REQUESTED THE LAB REPEAT THE TESTING DUE TO THE INCONSISTENT RESULTS. THE REPEAT TEST WAS UNDILUTED AND RESULTED IN A HIGH VALUE AGAIN. THE CUSTOMER REPEATED THE TEST AT 1:100 DILUTION AND THE RESULT WAS GREATER THAN 40,000MIU/ML. THE ANALYZER IS DOWN. ACCEPTABLE BHCG RANGE: 0.5MLU/ML - 400MLU/ML. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED POTENTIAL DISCREPANT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678111 ↗
• MalfunctionMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL DISCREPANT RESULTS FOR TESTOSTERONE (TES) ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THAT THE RESULTS WERE FROM A CISGENDER (CIS) MALE AND A CIS FEMALE. THE CUSTOMER IS CURRENTLY USING TES TEST CUP LOT NUMBER F6124C6. THE CIS MALE PATIENT HAD BLOOD SAMPLES DRAWN AND TESTED ON (B)(6) 2025, (B)(6) 2026, AND (B)(6) 2026 WITH A DIFFERENT RESULT EACH TEST. THE CUSTOMER STATED THEY EXPECTED THE PATIENT RESULTS TO STEADILY INCREASE DUE TO THE PHYSICIAN INCREASING THE PATIENT'S TES MEDICATION DOSAGE. THE CUSTOMER STATED THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH POST-TRAUMATIC STRESS DISORDER (PTSD); HOWEVER, IT WAS NOTED THAT THE INCREASE IN MEDICATION RESULTED IN PHYSIOLOGICAL AND PSYCHOLOGICAL EFFECTS ON THE PATIENT. ADDITIONAL DETAILS REGARDING THESE EFFECTS OR WHY THE PATIENT WAS PRESCRIBED TES MEDICATION OR PATIENT'S MEDICATION HISTORY WERE NOT PROVIDED. THE MALE PATIENT HAD A RECENT LAB DRAW, AND THE SAMPLE WAS SENT TO LABCORP FOR TESTING, RESULT OF SAMPLE WAS 1500 NG/DL, WHICH IS MUCH HIGHER THAN THE RESULTS PROVIDED ON THE TOSOH AIA-900 ANALYZER. LABCORP REFERENCE RANGE:264 NG/DL- 916 NG/DL. TOSOH REFERENCE RANGE: 199 NG/DL - 1586 NG/DL. DATE: AIA-90

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599274 ↗
• MalfunctionMar 9, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL DISCREPANT PATIENT RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), ESTRADIOL (E2), AND PROGESTERONE (PROG III) ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THEY INITIALLY NOTICED THE ISSUE WHEN MULTIPLE PROGESTERONE RESULTS RETURNED AS LESS THAN 0.1NG/ML, WHICH WAS UNUSUAL FOR THEIR PATIENT POPULATION. THE PROGESTERONE PATIENT RESULTS ALONG WITH BETA HUMAN CHORIONIC GONADOTROPIN AND ESTRADIOL PATIENT RESULTS WERE REPORTED OUT TO THE PATIENT(S) NURSING STAFF. THE RESULTS WERE QUESTIONED AND SAMPLES WERE RE-RUN, HOWEVER, THE NEW RESULTS WERE SIGNIFICANTLY DIFFERENT FROM THE INITIAL REPORTED RESULT. THE CUSTOMER CONFIRMED THAT ALL RE-RAN SAMPLES WERE PERFORMED SAME DAY AS THE ORIGINAL SAMPLE, USING THE ORIGINAL VIAL. THE SAMPLES WERE RAN WITH BHCG TEST CUP LOT F517107, E2 TEST CUP LOT F512948, AND PROG III TEST CUP LOT F71C321. IT WAS ALSO OBSERVED THAT E2 QUALITY CONTROL (QC) WAS OUT OF RANGE ON (B)(6) 2026 AND (B)(6) 2026 USING MAS LIQUIMMUNE CONTROLS LOT LIA28020A. THE WASH AND DILUENT WERE REPLACED ON 10FEB2026. THE CUSTOMER ALSO STATED THEY RECEIVED ERROR MESSAGE ¿2204 SORTER DID NOT PICK UP CUP¿ BUT IT WAS NOT A RECURRING ERROR MESSAGE. THE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553766 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL PATIENT RESULT DISCREPANCY FOR PROSTATE SPECIFIC ANTIGEN (PSA) ON THE AIA-900 ANALYZER. THE CUSTOMER STATED THE PATIENT USUALLY HAS A RESULT OF 0.04NG/M (ASSAY RANGE 0.05NG/M TO 100.0NG/M), HOWEVER THIS RESULT WAS SLIGHTLY ELEVATED TO 0.06 AND WAS QUESTIONED BY THE PATIENT PHYSICIAN. TECHNICAL SUPPORT SPECIALIST (TSS) FOLLOWED UP WITH THE CUSTOMER AND PROVIDED A COPY OF THE ANALYTE APPLICATE MANUAL (AAM) AND EXPLAINED TO THE CUSTOMER THAT THE LOWER DETECTION LIMIT IS 0.05NG/M WITH A SAMPLE VOLUME OF 20UL. IF THERE IS A POTENTIAL PIPETTING ISSUE, THAT COULD CREATE A SHIFT IN THE PATIENT RESULT. TSS SUGGESTED THE CUSTOMER PERFORM A PRECISION STUDY USING A SAMPLE AT THE LOW END, HOWEVER, TSS NOTED IT WAS VERY POSSIBLE THE CUSTOMER WOULD GET RESULTS OF "L (LOW)" OR "RESULTS ON THE LOW END OF THE RANGE". TSS ALSO POINTED OUT TO THE CUSTOMER, THAT PER THE AAM, IT IS RECOMMENDED TO TEST PSA IN CONJUNCTION WITH DRE (DIGITAL RECTAL EXAMINATION) IN DETECTING PROSTATE CANCER. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477160 ↗
• MalfunctionFeb 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED POTENTIAL PATIENT RESULT DISCREPANCY FOR PROSTATE SPECIFIC ANTIGEN (PSA) ON THE AIA-900 ANALYZER. THE CUSTOMER REPORTED AN INITIAL RESULT OF 0.11NG/M (ASSAY RANGE 0.05NG/M TO 100.0NG/M) TO THE PATIENT PHYSICIAN. THE PATIENT PHYSICIAN QUESTIONED THE RESULT DUE TO THE PATIENT NOT HAVING A PROSTATE. THE CUSTOMER RERAN THE SAMPLE THE FOLLOWING DAY, AFTER REFRIGERATION, AND RECEIVED AN EXPECTED RESULT OF LESS THAN LOW. THE CUSTOMER CONFIRMED THAT QUALITY CONTROL (QC) WAS IN RANGE AND NO OTHER ISSUES OCCURRED. THE CUSTOMER ALSO STATED THAT THERE WERE OVER TWENTY (20) OTHER PATIENT SAMPLES RAN WITH EXPECTED RESULTS OF LESS THAN LOW AND NO ISSUES. THERE WERE NO REAGENT CHANGES DURING THE PATIENT SAMPLE PROCESSING. TECHNICAL SUPPORT SPECIALIST (TSS) RECOMMENDED THE CUSTOMER CONFIRM THE PATIENT SAMPLE IN QUESTION DID NOT CONTAIN ANY FIBRIN AND TO RUN A PRECISION. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384065 ↗
• MalfunctionFeb 11, 2026Mechanical Problem

  A CUSTOMER REPORTED 4153 C.TRANS-Z HOME OVERRUN ERROR ON THE AIA-900 ANALYZER. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO POWER OFF THE ANALYZER, ENSURE THE WASTE BIN AND WASTE CHUTE WERE FREE OF DEBRIS, THEN RESTART THE ANALYZER AND PERFORM AN "ALL SET HOME" ACTION. THE ERROR RECURRED. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND PROGESTERONE III (PROG III). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318774 ↗
• MalfunctionFeb 9, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4253 WASH-SYR HOME OVERRUN¿ CAUSING THE RUN TO BE ABORTED ON THE AIA-900 ANALYZER. THE CUSTOMER COMPLETED AN ALL-SET-HOME AND PRIMED THE WASH. THE CUSTOMER ALSO VISUALLY INSPECTED THE WASH PROBES AND REPLACED THE TIPS. THE ERROR REOCCURRED WHILE RUNNING AND THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND PROGESTERONE (PROG III). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300161 ↗
• MalfunctionFeb 5, 2026Mechanical Problem

  A CUSTOMER REPORTED 4151 C.TRANS-Z HOME DETECT ERROR ON THE AIA-900 ANALYZER. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INSPECTED THE WASTE AND CHUTE FOR OBSTRUCTIONS, NONE WERE FOUND. TSS THEN INSTRUCTED THE CUSTOMER TO PERFORM AN ALL SET HOME, WITH THE ERROR RECURRING. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274421 ↗