IMMAGERecalls & reported problems across all models

We found 2 models of IMMAGE by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, 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).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

IMMAGE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 31, 2024Open, Classified

   Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

   Z-0118-2025 · Root cause: Employee error · Recall details · FDA record ↗

Most reported IMMAGE problems

IMMAGE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IMMAGE 447610

  Method, Nephelometric, Immunoglobulins (G, A, M)
  1 recall0 reports
• IMMAGE A15445

  Nephelometer, For Clinical Use
  4 reports

Recent IMMAGE adverse event reports

The 4 most recent reports across all models, 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 ↗

Other Beckman Coulter, Inc. products

• Cytomics FC5002 models · 1,337 reports
• DxC AU4 models · 632 reports · 8 recalls
• MicroScan10 models · 7 reports · 9 recalls
• Synchron7 models · 4 reports · 5 recalls
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2 models · 5 reports · 4 recalls
• UniCel DxH4 models · 74 reports · 2 recalls
• Access AccuTnI+32 models · 165 reports
• REMISOL Advance2 models · 0 reports · 2 recalls