ARCHITECT 7P32-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740129033), received between Nov 3, 2017 and Nov 26, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2018High Readings; High Readings

  THE CUSTOMER REPORTED THAT THEY ARE OBSERVING FALSELY ELEVATED TOTAL BILIRUBIN ON THEIR ARCHITECT COMPARED TO WHAT THEIR SISTER SITE IS GETTING ON BOTH PATIENT RESULTS AND CONTROLS. THE EXAMPLE RESULTS PROVIDED WERE FOR 2 ADULT PATIENTS: (B)(6) ON (B)(6) 2018 =1.9MG/DL (RANGE = 0-1.2MG/DL) / SAMPLE SENT TO ARUP = 1.1 / PREVIOUSLY ON (B)(6) 2017 BY ROCHE = 1.3; (B)(6) ON (B)(6) 2018 = 2.3MG/DL / SENT TO ARUP = 1.4 / PREVIOUSLY IN 2017 = 0.8 (UNKNOWN METHOD). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101461 ↗
• MalfunctionJul 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING TOTAL BILIRUBIN REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL AND REPEAT RESULTS READ 0.481 MG/DL (REPORTED AS LESS THAN 1.50 MG/DL). REPEAT USING ANOTHER ANALYZER 2.67, 2.74 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684141 ↗
• MalfunctionNov 3, 2017Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT TOTAL BILIRUBIN RESULT WAS GENERATED FOR A NEWBORN PATIENT (SAMPLE ID (B)(6)) ON (B)(6) 2017. INITIAL TESTING WAS 12.96 MG/DL. REPEAT TESTING WAS 0.57 MG/DL WHICH IS SUSPECTED TO BE FALSELY DECREASED. THE INITIAL HIGH RESULT WAS VERIFIED BY 1:1 DILUTION TESTING (12.10 MG/DL). THE CUSTOMER STATED THAT IT IS POSSIBLE THAT THE SECOND VALUE WAS GENERATED AFTER THE SAMPLE SAT FOR 30 MINUTES AT ROOM TEMPERATURE UNDER THE INFLUENCE OF LIGHT WHICH IS NOT IN ACCORDANCE WITH SAMPLE HANDLING INSTRUCTIONS IN THE REAGENT PACKAGE INSERT. THE CUSTOMER WILL ATTEMPT TO RETRACE THE HANDLING OF THIS SAMPLE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7001262 ↗