ARCHITECT 1P30-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740105327), received between Oct 23, 2019 and Oct 23, 2019 — 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.

• MalfunctionOct 23, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT IVANCOMYCIN RESULT ON ONE PATIENT. RESULTS PROVIDED: 29SEP2019 SID 410619 09/29/2019 = 1.36 / 26.47 / 25.15 UG/ML. NEW SAMPLE COLLECTED 4 HOURS LATER SID 410846 = 23.10 UG/ML. NORMAL RANGE FOR VANCOMYCIN: (TROUGH: 10 - 20 UG/ML; CRITICAL: >20 UG/ML). INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHARMACY AS IT DID NOT LINE UP WITH PREVIOUS RESULTS; TREATMENT HAD NOT BEEN ALTERED. PATIENT HAD BEEN RECEIVING VANCOMYCIN (INITIAL SPECIMEN WAS A TROUGH SAMPLE). PATIENT TREATMENT WAS NOT PROVIDED BASED ON THE INITIAL RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9224706 ↗