ARCHITECT 1P32-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740001766), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “High 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 16, 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.

• InjurySep 20, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED DIGOXIN (LN 1P32) RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FROM (B)(6): SID (B)(6), INITIAL 3.5 NMOL/L. THE DOCTOR TOOK THE PATIENT OFF DIGOXIN FOR 2 WEEKS TO MONITOR, YET THE PATIENT CONTINUED TO HAVE CRITICALLY HIGH LEVELS OF DIGOXIN. ON (B)(6): RESULT: 3.5 NMOL/L; AT ANOTHER HOSPITAL (ON SIEMENS ANALYZER) SAMPLE RESULTED AS 0.2 NMOL/L. ON (B)(6): RESULT: 3.2 NMOL/L; AT ANOTHER HOSPITAL (UNKNOWN METHOD) THE SAMPLE RESULTED AS 0.3 NMOL/L. NO OTHER PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7895367 ↗