IMMAGE A15445Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15099590265403), received between Jul 23, 2024 and Jan 9, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF FALSE PATIENT RESULTS ON THEIR IMMAGE 800 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024228 ↗
• InjurySep 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF A FALSE LOW RHEUMATOID FACTOR (RF) PATIENT RESULT ON THEIR IMMAGE 800 ANALYZER. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF HARM TO THE PATIENT. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20242725 ↗
• InjurySep 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULT FOR RHEUMATOID FACTOR (RF) ON THEIR IMMAGE 800 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DILUTED (1:36) THE SAMPLE AND REPEATED WITH RESULT WAS HIGHER. THE CUSTOMER ALSO REPEATED THE SAMPLE WITHOUT DILUTION ON ANOTHER ANALYZER AND RESULT WAS ALSO HIGHER. DUE TO RESULTS DISCREPANCY, THE CUSTOMER INDICATED THERE WAS A DELAY IN PATIENT TREATMENT. THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS REGARDING THIS PATIENT. THE CUSTOMER REPORTED THIS ADVERSE EVENT TO NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) FOR THE REPORTED DELAY IN PATIENT TREATMENT. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED THE RESULTS FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208769 ↗
• InjuryJul 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER QUESTIONED LOW RHEUMATOID FACTOR (RF) PATIENT RESULT ON THEIR IMAGE 800 ANALYZER. THE CUSTOMER STATED THE INACCURATE RESULTS RESULTED IN DELAY IN PATIENT TREATMENT FOR ONE (1) PATIENT. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING CHANGE IN PATIENT TREATMENT. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER PROVIDED A EXAMPLE OF RF RESULT.

  Patient problems: Insufficient Information

  MAUDE report 19802851 ↗