AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 STRecalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 04560189284616), received between Sep 7, 2018 and Sep 25, 2026 — classified as 295 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (176 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 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892556 ↗
• MalfunctionSep 18, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812767 ↗
• MalfunctionSep 18, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812754 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812721 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  A customer reported error 4193 (2000 only) Y-axis cup transfer Z-axis home overrun on the AIA-2000 analyzer. The customer confirmed the waste was not full, then attempted to perform an all set home and empty waste cup action, however, neither would complete. 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 50797380 ↗
• MalfunctionAug 27, 2026Mechanical Problem

  A customer reported "2250 sample loader rack X1-step feed failure" error on the AIA-2000 analyzer. The issue occurred after a rack jam. The customer removed the rack and performed an all-set-home, but the error persists. A Technical Support Specialist instructed the customer to power off, restart and check for any spills or debris in loader area. After rebooting, the error reoccurred when loading a rack. 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 50488478 ↗
• MalfunctionAug 14, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256552 ↗
• MalfunctionAug 12, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230239 ↗
• MalfunctionJul 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085761 ↗
• MalfunctionJul 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077809 ↗
• MalfunctionJul 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077789 ↗
• MalfunctionJun 3, 2026Computer Software Problem

  A CUSTOMER REPORTED THAT THE COMPUTER SHUT DOWN IN THE MIDDLE OF A RUN ON THE AIA-2000 ANALYZER. FOLLOWING THE COMPUTER RESTART, SAMPLES THAT WERE IN PROCESS AT THE TIME OF THE SHUTDOWN APPEARED IN THE SOFTWARE WITH REPORTED RESULTS, DESPITE THE RUN NOT HAVING BEEN COMPLETED. THE CUSTOMER STATED THAT THESE INCORRECT RESULTS REMAINED ON THE RESULTS LIST DESPITE CLEARING THE SPECIMEN DATABASE AND RESTARTING BOTH THE SOFTWARE AND COMPUTER. THE CUSTOMER THEN LOADED THREE NEW SAMPLES AND DURING THE RUN, THE SOFTWARE PROMPTED FOR A DILUTION ALTHOUGH NO DILUTION WAS REQUIRED. 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 25385961 ↗
• MalfunctionMay 11, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿2205 SORTER DROPPED CUP¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER IDENTIFIED A FALLEN TEST CUP IN THE SORTER AND REMOVED IT, BUT ERROR PERSISTS. 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). 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 25145176 ↗
• MalfunctionApr 24, 2026Mechanical Problem; Noise, Audible

  A CUSTOMER REPORTED "4111 (2000 ONLY) TEST CUP-TIP LANE HOME DETECTION FAILURE ERROR, 2060 (2000 ONLY) TIP ATTACHMENT FAILURE BY MAIN ARM ERROR, 4113 (2000 ONLY) TEST CUP-TIP LANE HOME OVERRUN ERROR, 0102 TIP SCAN FAILURE ERROR AND AN AUDIBLE NOISE ON THE AIA-2000 ANALYZER. THE CUSTOMER CHECKED THE TIP TRAY AREA AND RESEATED THE TRAYS. THE CUSTOMER NOTED THAT THERE WERE DROPPED CUPS AND TIPS. THE CUSTOMER ATTEMPTED TO RERUN THE ANALYZER, BUT ERRORS PERSISTED. 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 24991155 ↗
• MalfunctionApr 23, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4055 SORTER Z-AXIS MOTOR SLIPPAGE DETECTED AND 2070 CLOGGING DETECTED DURING SPECIMEN SUCTION BY MAIN ARM¿ ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) SUGGESTED THE CUSTOMER REBOOT AND PERFORM AN ALL-SET-HOME. WHILE RUNNING THE ANALYZER AN AUDIBLE GRINDING NOISE WAS HEARD, 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). 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 24974602 ↗
• MalfunctionApr 22, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4055 SORTER Z-AXIS MOTOR SLIPPAGE DETECTED¿ ERROR ON THE AIA-2000 ANALYZER. THE CUSTOMER HEARD AN AUDIBLE NOISE AND FOUND SEVERAL TEST CUPS INSIDE THE ANALYZER. THE CUSTOMER ALSO REMOVED THE TOP COVER AND FOUND THE PICK UP ARM HITTING THE BACK OF THE TIP DRAWER. IN ADDITION, THE CUSTOMER FOUND A METAL PIECE HANGING DOWN, AND UNSURE IF IT WAS BROKEN OR BECAME LOOSE. 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 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 24961052 ↗
• MalfunctionApr 15, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4224 INTERFERENCE OF DISPENSING NOZZLE Z-AXIS OF MAIN ARM" AND PATIENT NAMES ARE GREYED OUT ON THE AIA-2000 ANALYZER. THE CUSTOMER PERFORMED AN ALL-SET HOME. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REBOOT THE ANALYZER, CHECK THE WASTE, CHECK SETTINGS, AND RUN A SAMPLE, BUT THE ERROR PERSISTS. THE CONNECTIONS WERE CONFIRMED TO BE SECURED. 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 24891263 ↗
• MalfunctionApr 13, 2026Mechanical Problem

  A CUSTOMER REPORTED "4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN" ERROR ON THE AIA-2000 ANALYZER. 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 24854031 ↗
• MalfunctionApr 10, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGES ¿2240 B/F PROBE 2 PURGE FAILURE¿ DURING PATIENT PROCESSING ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO CHECK THE WASH SOLUTION FOR BUBBLES AND NONE WAS NOTED. TSS ALSO INSTRUCTED THE CUSTOMER TO RESET THE BF TIP #2 FOLLOW BY WASH PRIME. THE WASH PRIME PASSED. THE CUSTOMER RAN SAMPLES AND 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 24841637 ↗
• MalfunctionMar 30, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿2071 CLOGGING DETECTED DURING SPECIMEN DILUTING SOLUTION SUCTION BY MAIN ARM¿ ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO PERFORM THREE PRIMES AND RETRY RERUNNING, BUT 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 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 24708796 ↗
• MalfunctionMar 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FAILED AMERICAN PROFICIENCY INSTITUTE (API) 2026 CHEMISTRY CORE 1ST EVENT PROFICIENCY TESTING FOR INTACT PARATHYROID HORMONE (IPTH) ON THE AIA-2000 ANALYZER. THE TOSOH QUALITY ASSURANCE (QA) LABORATORY PASSED ALL API 2026 CHEMISTRY CORE 1ST EVENT PROFICIENCY TESTS. PRIOR TO TESTING THE API SURVEYS, THE CUSTOMER CALIBRATED IPTH AND RAN QC WITH PASSING RESULTS. THE CUSTOMER CONFIRMED THAT NO PATIENT RESULTS WERE AFFECTED AND THAT THE WASH AND DILUENT SAT FOR 24 HOURS PRIOR TO USE. THE CUSTOMER REQUESTED SERVICE TO CHECK THE ANALYZER. 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 24679068 ↗
• MalfunctionMar 22, 2026Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGES ¿2207 NO TIP ACQUIRED BY SORTER AND 2204 SORTER CUP PICKUP FAILURE¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER PERFORMED TWO VERSION UPS AND RESTARTED THE ANALYZER. NO FALLEN TEST CUPS WERE OBSERVED AND NO FALLEN TIPS, 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 24658108 ↗
• MalfunctionMar 12, 2026Mechanical Problem; Noise, Audible

  A CUSTOMER REPORTED 4031 SORTER X-AXIS HOME DETECTION FAILURE ERROR AND 4033 SORTER X-AXIS HOME OVERRUN ERROR ON THE AIA-2000 ANALYZER. THE CUSTOMER STATED THE ERRORS OCCURRED DURING PATIENT SAMPLE PROCESSING. THE CUSTOMER REBOOTED THE ANALYZER AND PERFORMED AN "ALL SET HOME" ACTION. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INSPECT THE WASTE TUBING FOR OBSTRUCTION AS WELL AS INSPECT THE TIP AND SORTER DRAWER. THE CUSTOMER WAS UNABLE TO OPEN THE TIP DRAWER VIA THE BUTTON ON THE ANALYZER, HOWEVER, THE CUSTOMER WAS ABLE TO OPEN THE TIP DRAWER MANUALLY. THERE WERE NO OBSTRUCTIONS OBSERVED. THE CUSTOMER RESTARTED THE ANALYZER AND THE MECHANICAL ARM WAS MAKING AN AUDIBLE NOISE. 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 24587461 ↗
• MalfunctionMar 5, 2026Mechanical Problem; Communication or Transmission Problem

  A CUSTOMER REPORTED ERROR MESSAGES ¿3036 DETECTOR TEMPERATURE LOWER LIMIT ERROR, 3039 SUBSTRATE TEMPERATURE LOWER LIMIT ERROR, AND ERROR ON THE AIA-2000 ANALYZER STATING AIA-2000 CONTROLLER STARTED WITHOUT ANALYZER AND COM PORT ALREADY OPEN" (HOST COMMUNICATION ERROR) ON THE AIA-2000 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER MULTIPLE TIMES AND CONFIRMED ALL CABLES WERE SECURE, 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 24527079 ↗
• MalfunctionFeb 11, 2026Computer Operating System Problem

  A CUSTOMER REPORTED "STARTUP REPAIR AND BACKUP FAILED ON THE COMPUTER¿ UNABLE TO LAUNCH SOFTWARE ISSUES ON THE AIA-2000 ANALYZER. THE CUSTOMER REBOOTED THE COMPUTER, BUT THE ISSUE PERSISTS. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO SHUTDOWN THE COMPUTER AND ANALYZER. UPON STARTING UP, THE COMPUTER DISPLAYED, CHOOSE KEYBOARD LAYOUT, AND IS SLOW. THE SOFTWARE WILL STILL NOT LAUNCH. 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 24318756 ↗