AQURE 933-599Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05700699335999), received between Aug 29, 2022 and Nov 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 8, 2023Class IIOpen, Classified

   Due to potential software issue that may result in patient mix-up information.

   Z-1394-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Nov 23, 2016Class IITerminated

   Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

   Z-0899-2017 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Communication or Transmission Problem; Patient Data Problem; Communication or Transmission Problem; Patient Data Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025, THE CUSTOMER EXPERIENCED INCORRECT VALUE DISPLAY IN AQURE. SAMPLE TYPE PARAMETER "FIBTEM C" WAS SENT AS "---" (INDICATING AN INVALID OR MISSING RESULT) IS DISPLAYED AS AN INCORRECT NUMERICAL VALUE IN THE AQURE WEB INTERFACE. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616065 ↗
• MalfunctionSep 15, 2025Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE RESULT VALUES DID NOT MATCH AFTER UNIT CONVERSION FACTOR WAS APPLIED BETWEEN THE ANALYZER PATIENT DATA LOGS AND AQURE (SERIAL NUMBER: (B)(6)). OUT OF 583 RESULTS, 21 OF THEM DID NOT MATCH. THIS WAS NOT USED DURING TREATMENT OF PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050156 ↗
• MalfunctionAug 11, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER IS HAVING ISSUES REPROCESSING RESULTS, AS AN ERROR HAPPENS AFTER ADT LOOK UP WITH AQURE. THE LOOK UP HAS BEEN SUCCESSFUL AS THE LOOK UP BOX IS BELOW THE ERROR BOX. THIS HAPPENS WHEN THE USER PRESSED "OK". [AFTER CLICKING ON INITIAL 'OK', IT RETURNS, 'SAVE ERROR': 'THE SERVER DID NOT SAVE THE SAMPLE. CHECK YOUR NETWORK CONNECTION OR TRY AGAIN LATER.'] THE RESULT THEN STAYS AS PENDING BUT CANNOT BE REPROCESSED [AFTER REPROCESSING, PATIENT DEMOGRAPHICS WAS UPDATED BUT RESULT IS IN "APPROVAL STATUS: PENDING", BUT THE PATIENT DEMOGRAPHICS ARE POPULATED]. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768940 ↗
• MalfunctionNov 29, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER ENTERED THE WRONG PATIENT DATA THROUGH MANUAL ENTRY ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) . THE CUSTOMER THEN APPROVED THE SAMPLE RESULTS FOR THE WRONG PATIENT. THE RESULTS CROSSED OVER TO AQURE AND THEN TO EHR/HIS TO THE WRONG PATIENT. THE CUSTOMER THEN CORRECTED THE PATIENT DEMOGRAPHICS ON THE SAMPLE ON THE MACHINE, LINKING THE RESULTS TO THE CORRECT PATIENT, BUT THIS WAS ONLY CHANGED IN AQURE AND NOT OVER TO THEIR EHR/HIS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225889 ↗
• MalfunctionMay 15, 2023Communication or Transmission Problem; Communication or Transmission Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER IS FACING AN ISSUE ON AQURE (VERSION 2.6.1) WHEN RECEIVING PARAMETER CRP FROM LUMIRADX(THIRD-PARTY-DEVICE). WHEN LUMIRADX SENDS <5,0 TO AQURE, THE AQURE SYSTEM SHOWS 50 MG/L. ANOTHER EXAMPLE SHOWS A MEASUREMENT OF 33,4 MG/L WHERE AQURE SHOWS 334 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929025 ↗
• MalfunctionDec 13, 2022Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED A MPI (MASTER PATIENT INDEX) ISSUE WITH NONE RADIOMETER DEVICE LUMIRADX ON AQURE (VERSION 2.6.0.). THE QUERY ON LUMIRADX WITH ABNORMAL QUERY SUCCESS ON THE DEVICE WITH ERROR MESSAGE (ON DEVICE) FOLLOWING QUERY. DEVICE SOFTWARE VERSION: DEVICE:V1.21-HUB:V4.2.14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968383 ↗
• MalfunctionAug 29, 2022Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  THE CUSTOMER COMPLAINS ABOUT A PROBLEM WITH AQURE. ACCORDING TO THE COMPLAINT THE CUSTOMER MADE SOME TESTS BASED ON A PROBLEM THEY HAVE WITH A NOT RADIOMETER DEVICE (LUMIRADX). ONCE BY SCANNING A PATIENT TEST ID THE CUSTOMER RECEIVED INFORMATION FROM ANOTHER PATIENT TEST ID. SCENARIO OUTLINED: A) QUERY FROM ANALYZER FOR PATIENT 1234 B) QUERY FAILS C) QUERY FOR PATIENT ABCD D) ANALYZER RECEIVES INFORMATION FOR PATIENT 1234 IMMEDIATELY AFTER THE INCIDENT THE QUERY FUNCTIONALITY WAS DISABLED, HENCE PREVENTING FURTHER INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309348 ↗