AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04560189284623), received between Sep 1, 2021 and Sep 24, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (26 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876582 ↗
• MalfunctionMay 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED IMPRECISION OF QUALITY CONTROL (QC) RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND HUMAN CHORIONIC GONADOTROPIN (HCG) ON THE AIA-2000 ANALYZER. THE CUSTOMER STATED THERE WAS NO SPECIFIC PATTERN TO THE IMPRECISION. 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 HUMAN CHORIONIC GONADOTROPIN (HCG). 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 25133628 ↗
• MalfunctionMar 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED ¿BH SUBSTRATE BACKGROUND HIGH FLAG¿ DUE TO HIGH SUBSTRATE VALUES DURING THE DAILY CHECK ON THE AIA-2000 ANALYZER. ONE BOTTLE OF SUBSTRATE INCREASED FOUR TIMES, AND THE SECOND SUBSTRATE BOTTLE INCREASED TEN TIMES THE VALUES AND FAILED THE DAILY CHECK. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO PERFORM A WEEKLY SUBSTRATE MAINTENANCE WITH NITRIC ACID AND OPEN ANOTHER SUBSTRATE FROM ANOTHER BOX. THE ISSUE PERSISTS 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). 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 24671262 ↗
• MalfunctionNov 6, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4051 SORTER Z-AXIS HOME DETECTION FAILURE¿ ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO RESEAT REAGENT TIPS, OBSERVED FOR DROPPED TEST CUPS, AND PERFORM AN ALL-SET HOME. THE ERROR PERSIST. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN DELAYED REPORTING OF PATIENT SAMPLES FOR (BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), AND HUMAN CHORIONIC GONADOTROPIN (HCG). 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 23493060 ↗
• MalfunctionOct 23, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED 4153 (2000 ONLY) X-AXIS CUP TRANSFER X-AXIS HOME OVERRUN ERROR ON THE AIA-2000 ANALYZER. THE CUSTOMER CHECKED FOR OBSTRUCTIONS WITHIN THE ANALYZER AS WELL AS LOOKED IN THE TEST CUP AREA FOR ANY DROPPED CUPS AND FOUND NONE. THE CUSTOMER THEN POWERED DOWN AND RESTARTED THE ANALYZER AND PERFORMED AND ALL SET HOME. 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). 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 23375720 ↗
• MalfunctionSep 11, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED 4193 (2000 ONLY) Y-AXIS CUP TRANSFER Z-AXIS HOME OVERRUN ERROR ON THE AIA-2000 ANALYZER. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REBOOT THE ANALYZER, BUT THE ERROR RECURRED. 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 23034110 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER OBSERVED THE WASTE BIN WAS NOT FULL, PERFORMED AN ALL-SET-HOME, FOLLOWED WITH A REBOOT; HOWEVER, THE PROCESS DID NOT 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 22857162 ↗
• MalfunctionAug 11, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ¿2233 B/F PROBE 3 OVERFLOW SENSOR FAILURE, 2234 B/F PROBE 4 OVERFLOW SENSOR FAILURE, 2235 B/F PROBE 1 SUCTION FAILURE AND WU B/F SEPARATION FAILURE" DURING DAILY CHECKS AND PATIENT PROCESSING ON THE AIA-2000 ANALYZER. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO VERIFY THE PROBES WERE NOT SWITCHED AND TIPS WERE SECURE; NO ISSUES WERE OBSERVED. 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 HUMAN CHORIONIC GONADOTROPIN (HCG). 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 22771974 ↗
• MalfunctionJun 9, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ¿4113 TEST CUP-TIP LANE HOME OVERRUN¿ ERROR ON THE AIA-2000 ANALYZER. THE CUSTOMER STATED NO OBSTRUCTIONS WERE OBSERVED, THE TIP TRAY AREA WAS CLEAR AND THE TIPS WERE SEATED PROPERLY. THE CUSTOMER ATTEMPTED TO PERFORM AN ALL-SET-HOME, 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 BETA HUMAN CHORIONIC GONADOTROPIN (HCG) AND HCG (HUMAN CHORIONIC GONADOTROPIN). 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 22172880 ↗
• MalfunctionJan 28, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED "4033 SORTER X-AXIS HOME OVERRUN AND 4063 SORTER TIP PICKUP Z-AXIS HOME OVERRUN" ERRORS 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) AND HUMAN CHORIONIC GONADOTROPIN (HCG). 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 21260889 ↗
• MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED "2235 B/F PROBE 1 SUCTION FAILURE" ERROR ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REMOVE THE WASH PROBE TIP, CLEAN AND RESEAT IT AND VISUALLY CHECK THE BF PROBE AREA. THE CUSTOMER NOTED LIQUID IN THE WELL AND TRIED PRIMING THE BF PROBES, BUT PROBE 1 WAS SLUGGISH AND DID NOT SEEM TO BE PRIMING CORRECTLY. 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 HUMAN CHORIONIC GONADOTROPIN (HCG). 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 21213945 ↗
• MalfunctionDec 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  A CUSTOMER REPORTED 4143 SEAL BREAKER HOME OVERRUN ON THE AIA-2000 ANALYZER. THE ANALYZER IS DOWN AND THE CUSTOMER HAS REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) AND HUMAN CHORIONIC GONADOTROPIN (HCG). 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 20875278 ↗
• MalfunctionNov 5, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿2061 TIP DETACHMENT FAILURE BY MAIN ARM¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER CONFIRMED THE WASTE BIN WAS NOT FULL 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). 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 20614503 ↗
• MalfunctionAug 15, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED 4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN ON THE AIA-2000 ANALYZER. THE CUSTOMER VERIFIED THAT THE WASTE BIN WAS NOT FULL AND INDICATED THAT THEY PERFORMED AN ALL SET HOME FUNCTION, BUT IT WOULD NOT FULLY COMPLETE. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAY IN PATIENT RESULTS 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 19989915 ↗
• MalfunctionApr 28, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED 4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN ERROR ON THE AIA-2000 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER BUT ERROR PERSISTS. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO INSPECT THE ANALYZER FOR FALLEN TEST CUPS AND CONFIRM THE WASTE CHUTE WAS NOT OBSTRUCTED. 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 19199309 ↗
• MalfunctionApr 26, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGES 2205 SORTER DROPPED CUP AND 4043 SORTER Y-AXIS HOME OVERRUN ON THE AIA-2000 ANALYZER. THE CUSTOMER PERFORMED AN ALL SET HOME AND CHECKED SORTER FOR DROPPED OR MISSING CUPS AND FOUND NONE. THE CUSTOMER THEN REBOOTED THE ANALYZER, RAN A SAMPLE, BUT ERROR 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 BHCG (BETA HUMAN CHORIONIC GONADOTROPIN) AND HUMAN CHORIONIC GONADOTROPIN (HCG). 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 19197405 ↗
• MalfunctionMar 10, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED "WASH PROBE NUMBER ONE (1) IS LOOSE" ON THE AIA-2000 ANALYZER. WHEN THE CUSTOMER PERFORMED DAILY MAINTENANCE, THEY NOTICED THE PROBE WAS NOT STABLE AND HAD A LOT OF WIGGLE ROOM. THE CUSTOMER ALSO NOTICED A WHITE PIECE ON THE PROBE THAT WAS LOOSE. THE PIECE WAS PREVIOUSLY ABLE TO BE TIGHTENED TO LIMIT MOVEMENT, BUT THE SCREW IS NOW STRIPPED, NOT ALLOWING IT TO SECURE WASH PROBE NUMBER ONE (1). 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 18872237 ↗
• MalfunctionFeb 6, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE ¿4451 B/F PROBE 2 HOME DETECTION FAILURE¿ ON THE AIA-2000 ANALYZER. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO PERFORM A VERSION UP (SOFTWARE RELOAD) AND REBOOT 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 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 18656035 ↗
• MalfunctionFeb 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED OUT OF RANGE QUALITY CONTROL (QC) RESULT FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) ON THE AIA-2000 ANALYZER. THE CUSTOMER CONFIRMED QUARTERLY MAINTENANCE AND WASH PROBE MAINTENANCE WERE PERFORMED AND RECALIBRATED USING A NEW QC, BUT ISSUE 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). 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 18637661 ↗
• MalfunctionDec 10, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED 4241 (2000 ONLY) HYBRID ARM Y-AXIS HOME DETECTION FAILURE 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 ALPHA-FETOPROTEIN (AFP) 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 18298656 ↗
• MalfunctionAug 16, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR 2075 (2000 ONLY) AIR DETECTED DURING SPECIMEN SUCTION BY MAIN ARM ON THE AIA-2000 ANALYZER. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PATIENT SAMPLES FOR ALPHA-FETOPROTEIN (AFP). 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 17561651 ↗
• MalfunctionJul 13, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THAT THEY WERE UNABLE TO TURN ON THE COMPUTER FOR THEIR AIA-2000 ANALYZER. THE CUSTOMER TRIED REBOOTING A FEW TIMES WITHOUT SUCCESS. 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 ALPHA-FETOPROTEIN (AFP). 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 17322453 ↗
• MalfunctionJul 9, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGES "4211 MAIN ARM Y-AXIS HOME DETECTION FAILURE AND 4224 MAIN ARM Z-AXIS LIMIT OVERRUN¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER AND PERFORMED AN ALL SET HOME, BUT THE ARM DID NOT MOVE. TECHNICAL SUPPORT SPECIALIST (TSS) HAD CUSTOMER CHECK FOR OBSTRUCTION IN WASTE OR PROBE, NONE FOUND. 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 ALPHA-FETOPROTEIN (AFP). 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 17284314 ↗
• MalfunctionJun 25, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED OUT OF RANGE QUALITY CONTROL (QC) FOR CA125, 27.29, CA-19.9, AND CEA ON THE AIA-2000 ANALYZER. ALL VALUES WERE MORE THAN 50 PERCENT DIFFERENT COMPARED TO RUNNING THE SAME QC ON THE CUSTOMERS SECOND AIA-2000 ANALYZER. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR ALPHA-FETOPROTEIN (AFP) . THERE IS NO INDICATION OF ANY INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196197 ↗
• MalfunctionJun 20, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED ERROR MESSAGE "4223 MAIN ARM Z-AXIS HOME OVERRUN¿ ON THE AIA-2000 ANALYZER. THE CUSTOMER VERIFIED WASTE BIN WAS NOT FULL, BUT FOUND A SCREW THAT WAS LOOSE INSIDE. 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 ALPHA-FETOPROTEIN (AFP). 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 17167999 ↗