cobas ISE neo 1800 analytical unit 09687416001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336224397), received between May 8, 2026 and May 8, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE ASSAY RESULTS FROM SEVEN PATIENT SAMPLES TESTED ON THE COBAS ISE NEO 1800 ANALYTICAL UNIT. ON (B)(6) 2026: PATIENT SAMPLE 1. THE INITIAL RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 129 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. PATIENT SAMPLE 3: THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. PATIENT SAMPLE 4: THE INITIAL RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. PATIENT SAMPLE 5: THE INITIAL RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. PATIENT SAMPLE 6: THE INITIAL RESULT WAS 137 MMOL/L. THE REPEAT RESULT WAS 147 MMOL/L. ON (B)(6) 2026: PATIENT SAMPLE 7: THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125406 ↗