ARCHITECT 01P3227Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740155988), received between Feb 19, 2020 and Feb 19, 2020 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 19, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED DIGOXIN RESULTS FOR MULTIPLE PATIENTS, WHEN PROCESSING ON THE ARCHITECT I2000SR. THE CUSTOMER STATED SAMPLES THAT GENERATED A RESULT OF <0.4 WERE SENT TO ANOTHER HOSPITAL TO BE TESTED WITH A DIFFERENT INSTRUMENT. ADDITIONALLY, THE CUSTOMER REPORTED THAT ONE OF THE PATIENTS (SID UNKNOWN) WAS TREATED WITH AN EXCESS DIGOXIN DOSE AS A RESULT OF THE FALSE DECREASED DIGOXIN RESULT. RESULT FOR THIS PATIENT WAS <0.4 ON THE ARCHITECT AND AT ANOTHER HOSPITAL THE ORTHO INSTRUMENT GENERATED A RESULT OF 2.15. THE CUSTOMER STATED THERE WAS NO ADVERSE IMPACT TO THE PATIENT AS A RESULT OF THE DIGOXIN TREATMENT. THE FOLLOWING DATA WAS PROVIDED, SIDS ARE UNKNOWN (FIRST VALUE CORRESPONDS TO THE I2000SR RESULT AND SECOND VALUE IS THE RESULT GENERATED USING VITROS METHOD): 0.5 AND 1.26. 0.7 AND 1.46. <0.4 AND 0.6. <0.4 AND 0.7. 1.1 AND 1.38. SID (B)(6): <0.4 AND 3.59. SID (B)(6): <0.4 AND 2.68. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9728838 ↗