AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 04560189282896), received between Jul 24, 2018 and Sep 30, 2026 — classified as 247 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (117 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 247 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported failing American Proficiency Testing (API) second event Chemistry Core proficiency testing for Cardiac Troponin I (cTnl2) sample CM-09 and Creatine Kinase MB (CK-MB) samples CM-07, CM-08, and CM-09 on the AIA-360 analyzer. The customer stated the testing was performed on (b)(6)2026, however, Tosoh was not notified of the failed API testing until 31AUG2026. Technical Support Specialist (TSS) reviewed the customer's calibration and quality control data, with no issues found. Periodic Maintenance (PM) was performed on 05JUN2026 after the API failure. After the PM, the AIA-360 analyzer was confirmed to operate as expected. The customer retested API in (b)(6)2026, and all result passed. The Tosoh Quality Assurance (QA) lab passed all samples for API testing. No further action required by Technical Support Specialist. 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 50947422 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892548 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876614 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812726 ↗
• MalfunctionSep 9, 2026Mechanical Problem

  A customer reported failure mode ¿2012 Air Detected (Diluent)¿ on the AIA-360 analyzer. The customer primed the analyzer and no air was noted in the lines. 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 50682351 ↗
• MalfunctionSep 2, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554646 ↗
• MalfunctionAug 17, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268899 ↗
• MalfunctionAug 16, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268635 ↗
• MalfunctionAug 11, 2026Device Ingredient or Reagent Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216919 ↗
• MalfunctionAug 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported failed American Proficiency Institute (API) second event proficiency testing for Free Triiodothyronine (FT3) on the AIA-360 analyzer. Samples CH-06 and CH-10 failed, and no additional information has been provided. Tosoh quality laboratory participated in the American Proficiency Institute (API) second event proficiency testing for Free Triiodothyronine (FT3) and passed all results. A Field Service Engineer (FSE) was dispatched to address the reported event. 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 50189344 ↗
• MalfunctionAug 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133005 ↗
• MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094083 ↗
• MalfunctionJun 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FAILED PROFICIENCY TESTING OF ONE PROGESTERONE II SAMPLE FOR THE AMERICAN ASSOCIATION OF BIOANALYSTS-MEDICAL LABORATORY EVALUATION (AAB-MLE) ON THE AIA-360 ANALYZER. THIS PROFICIENCY TESTING FAILED (B)(6) 2026, BUT WAS NOT REPORTED TO TOSOH UNTIL 26MAY2026. THE FAILED AAB-MLE SAMPLE WAS 1.3 NG/ML (EXPECTED RANGE 1.8 - 3.1NG/ML) USING TEST CUP LOT FX1C7A9. THE CUSTOMER CONFIRMED REMAINING SURVEY SAMPLES PASSED FOR PROG II. THE CUSTOMER INITIALLY CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE AND WAS INSTRUCTED TO COMPLETE THE SIX-MONTH MAINTENANCE; HOWEVER, THE ISSUE REMAINED. THE FSE THEN REQUESTED THE CUSTOMER RUN A PRECISION STUDY AND THE RESULTS SHOWED LEVEL 3 COEFFICIENT OF VARIATION (CV) WAS HIGH, INDICATING IMPRECISION. THE CUSTOMER RECENTLY RECALIBRATED THE ASSAY, WHICH RESULTED IN AN INCREASE IN QUALITY CONTROL (QC). THE CUSTOMER STATED THE QC PERFORMANCE HAS NOT BEEN CONSISTENT, ALTHOUGH THE RESULTS HAVE REMAINED WITHIN THE ACCEPTABLE RANGE. TOSOH DID NOT PARTICIPATE IN THE PROG II PROFICIENCY TESTING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555803 ↗
• MalfunctionJun 8, 2026Mechanical Problem

  A CUSTOMER REPORTED THE WASTE TUBING CONNECTION LEAKING FROM THE BACK OF THE AIA-360 ANALYZER. THE CUSTOMER STATED THE LEAK WAS NOT COMING FROM THE OVERFLOW TUBING. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO ATTEMPT TO RESEAT THE CONNECTION, BUT THE CUSTOMER FOUND A CRACK IN THE TUBING. 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 25437789 ↗
• MalfunctionJun 2, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿3003 WAITING FOR TEMPERATURE¿ ON THE AIA-360 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER, BUT THE ERROR PERSISTS. 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 25368516 ↗
• MalfunctionMay 21, 2026Mechanical Problem

  A CUSTOMER REPORTED ¿4002 TURN TABLE HOME NOT FOUND AND 4004 TURN TABLE SLIP FAILURE ERRORS¿ ON THE AIA-360 ANALYZER. THE CUSTOMER WAS ABLE TO POWER DOWN THE ANALYZER AND PHYSICALLY MOVE THE CAROUSEL, PERFORM AN ALL-SET-HOME, AND RUN A FEW SAMPLES, BUT ERRORS PERSIST. 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 25250354 ↗
• MalfunctionMay 1, 2026Device Ingredient or Reagent Problem

  A CUSTOMER REPORTED DISCREPANT PATIENT RESULTS FOR BETA HUMAN CHORIONIC (BHCG) AND PROGESTERONE (PROG III) ON THE AIA-360 ANALYZER. ON (B)(6) 2026, THE RESULT FOR BHCG WAS 38.075 MIU/ML (ACCEPTABLE RANGE 0.5-400.0MIU/ML). THE PHYSICIAN WANTED THE BHCG SAMPLE SENT TO A REFERENCE LABORATORY (LABCORP) DUE TO THE HIGH BHCG RESULT. THE LABCORP RESULT WAS 18.467 MIU/ML AND THE ACCEPTABLE RANGE FOR LABCORP IS UNKNOWN. THE CUSTOMER WAS CONCERNED OF THE SIGNIFICANT DIFFERENCE BETWEEN THE INHOUSE RESULT AND LABCORB VALUES. THE CUSTOMER ALSO STATED THE CONTROLS FOR BOTH BHCG AND PROG III HAVE BEEN DRIFTING OUT OF RANGE. WHILE TECHNICAL SUPPORT SPECIALIST (TSS) WAS TROUBLESHOOTING WITH THE CUSTOMER OVER THE PHONE, THE CUSTOMER NOTICED THE BHCG TEST CUPS HAD EXPIRED; LOT F317106 EXPIRATION DATE 02/28/2026. THE CUSTOMER CALIBRATED A NEW BHCG LOT AND RESOLVED THE BHCG QUALITY CONTROL (QC) ISSUE. FOR PROG III, THE RESULT WAS 19.14 NG/ML (ACCEPTABLE RANGE 0.10-40.0NG/ML), USING TEST CUP LOT F71C320, THE SAMPLE WAS ALSO SENT TO LABCORP FOR COMPARISON AND LABCORP RESULT WAS 12.1 NG/ML. THE PROG III RESULT WAS WITHIN ACCEPTABLE RANGE, BUT CUSTOMER'S PROG III EXPECTED VALUE WAS NOT PROVIDED. THE CUSTOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057922 ↗
• MalfunctionApr 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED DISCREPANT RESULTS FOR THYROID STIMULATING HORMONE (TSH) ON THE AIA-360 ANALYZER. THE CUSTOMER RUNS IN CUPS AS WELL AS IN THE TUBES BUT THE ISSUE OCCURS WHEN RUNNING BOTH. QUALITY CONTROL (QC) AND CALIBRATION ARE WITHIN RANGE. THE FIRST RUN THE CUSTOMER RECEIVED LESS THAN LOW (<L), THE SECOND RUN WAS 1.67 MIU/ML AND THE THIRD RUN WAS 1.77MIU/ML. THE RESULTS FROM THE SECOND RUN WERE REPORTED OUT. THE CUSTOMER IS NOW CONCERNED THAT THEY MAY HAVE DISCREPANT RESULTS FOR CARDIAC TROPONIN I (CTNL 2) AS WELL. THE CUSTOMER CONFIRMED NO BUBBLES WERE PRESENT IN SAMPLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR FURTHER INVESTIGATION. 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 25021611 ↗
• MalfunctionApr 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ALL FIVE LEVELS OF AMERICAN ASSOCIATION OF BIOANALYSTS-MEDICAL LABORATORY EVALUATION (AAB-MLE) PROFICIENCY TESTING FAILED IN SEPTEMBER 2025 AND FEBRUARY 2026 FOR LUTEINIZING HORMONE (LH II) ON THE AIA-360 ANALYZER. THE FAILED PROFICIENCY TESTING FROM SEPTEMBER 2025 WAS NOT REPORTED TO TOSOH AT THE TIME OF OCCURRENCE. THE TOSOH QUALITY ASSURANCE (QA) LABORATORY PASSED ALL AAB-MLE M3 (B)(6) 2025 AND AAB-MLE M1 (B)(6) 2026 PROFICIENCY TESTING. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN RANGE, ALL OTHER ANALYTES PASSED AND THE SHIPMENT WAS RECEIVED WITH NO ISSUES NOTED. A TECHNICAL SUPPORT SPECIALIST OFFERED TO SEND MULTI ANALYTE CONTROL (MAC) CONTROLS, BUT CUSTOMER REQUESTED SERVICE AS THIS IS THE SECOND TIME THEY HAVE FAILED THE PROFICIENCY TEST FOR LH II. FIELD SERVICE WAS DISPATCHED FOR FURTHER INVESTIGATION. 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 24921303 ↗
• MalfunctionApr 6, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGES ¿5032 CSUM ERROR (ERRLOG), 5033 CSUM ERROR (OPERATION LIST), 5029 CSUM ERROR (PARAM), 5030 CSUM ERROR (REAGENT), 5031 CSUM ERROR (RESULT), 2001 RTC POWER ON CLEAR, AND 5002 NO RESPONSE FROM SLAVE¿ ON THE AIA-360 ANALYZER. THE CUSTOMER STATED THE BUILDING EXPERIENCED A POWER SURGE THE PREVIOUS DAY. THE CUSTOMER STATED THE ANALYZER IS PLUGGED DIRECTLY INTO THE WALL AND POWERED OFF THE ANALYZER AGAIN, BUT ERRORS 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 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 24795766 ↗
• MalfunctionApr 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿HIGH OUT OF RANGE LEVEL 1 QUALITY CONTROL (QC) FOR PROGESTERONE (PROG III)¿ ON THE AIA-360 ANALYZER. THE CUSTOMER RECALIBRATED THE ASSAY, MADE NEW CONTROLS, VERIFIED THE WASH AND DILUENT WERE PROPERLY EQUILIBRATED. THE SUBSTRATE WAS CONFIRMED TO BE WITHIN EXPIRATION. THE CUSTOMER WAS USING BIORAD LOT # 400481 AND TOSOH TEST CUP LOT # F71C320 WHICH RESULTED WITH 4.99NG/ML (EXPECTED INSERT PACKAGE RANGE 0.450NG/ML ¿ 0.830NG/ML). THE CUSTOMER PLANNED TO PERFORM A SIX-MONTH DECONTAMINATION PROCEDURE FOLLOWED BY RECALIBRATION. UPON FOLLOW-UP THE ISSUE PERSISTED. THE TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THE CUSTOMER WAS USING FROZEN ALIQUOTS FOR BIORAD CONTROLS AND INSTRUCTED THE CUSTOMER ON OPENING A NEW BIORAD BOTTLE AND REPEATED TESTING. TSS SHIPPED MULTI ANALYTE CONTROL (MAC) CONTROLS AND CALIBRATIONS TO RERUN QC TESTING; HOWEVER, THE CUSTOMER REPORTED AND ISSUE PERSISTS. 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 RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787006 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED "ALL QUALITY CONTROL (QC) IS OUT OF LINEARITY" ON THE AIA-360 ANALYZER. THE CUSTOMER STATED THE DAILY CHECK PASSED, INSTALLED A NEW WASH SOLUTION, DILUENT, AND SUBSTRATE; ALL WERE EQUILIBRATED OVERNIGHT. THERE WERE NO FLAGS OR ANALYZER ERROR CODES OTHER THAN LINEARITY IS OUT FOR ALL QC. THE ANALYZER POWER WAS RESET, BUT ISSUE PERSISTS. 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 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 24725763 ↗
• MalfunctionMar 24, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿3019 WASHER LOW,¿ ALTHOUGH THE WASH CONTAINER WAS FULL ON THE AIA-360 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) ARRANGED TO SHIP A REPLACEMENT WASH SENSOR AND ADVISED THE CUSTOMER TO RETRY AFTER INSTALLATION. THE ANALYZER IS DOWN. A TECHNICAL SUPPORT SPECIALIST (TSS) SHIPPED A REPLACEMENT WASH SENSOR 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 24680950 ↗
• MalfunctionMar 17, 2026Low Readings

  A CUSTOMER REPORTED "FOLLICLE STIMULATING HORMONE (FSH) QUALITY CONTROL (QC) LOW OUT OF RANGE" ON THE AIA-360. THE CUSTOMER USED TOSOH FSH TEST CUP LOT # F616824 AND RECENTLY SWITCHED TO A NEW BIO-RAD LOT # 85390. A TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO MIX WASH AND RERUN QC, BUT QC WAS STILL OUT OF RANGE. A TSS SENT NEW CALIBRATORS TO THE CUSTOMER AND CALIBRATION PASSED WITHOUT ERRORS, CALIBRATOR LOTS WERE NOT PROVIDED. THE CUSTOMER WAS ABLE TO RUN QC WITHOUT ISSUES. NO FURTHER ACTION REQUIRED BY TSS. THE AIA-360 ANALYZER IS FUNCTIONING AS EXPECTED. THE REPORTED EVENT RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR FOLLICLE STIMULATING HORMONE (FSH). 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 24624086 ↗
• MalfunctionMar 5, 2026Low Readings

  A CUSTOMER REPORTED "LOW QUALITY CONTROL (QC) LEVEL 1 FOR PROGESTERONE III (PROG III)" USING BIO-RAD LOT # 40470 ON THE AIA-360 ANALYZER. THE LEVEL 1 QC RESULT WAS 0.44 NG/ML AND WAS RERAN AND RESULTED WITH 0.30 NG/ML (EXPECTED RANGE 0.520 NG/ML - 0.960 NG/ML). LEVEL 3 QC RESULT WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER MADE FRESH WASH SOLUTIONS, AND A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER THAT THE WASH MUST SIT FOR 24 HOURS PRIOR TO USE. AFTER LETTING THE WASH SIT 24 HOURS, THE CUSTOMER RECALIBRATED, BUT THE ISSUE REMAINED. THE CUSTOMER CALLED BACK THE FOLLOWING DAY AND PERFORMED A DECONTAMINATION; LEVEL 1 QC IS STILL OUT AND NOW LEVEL 3 IS OUT OF RANGE LOW FOR PROG III. 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 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 24527035 ↗