ARCHITECT 1L76-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740001346), received between Aug 26, 2016 and Feb 20, 2018 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT SIROLIMUS RESULTS FOR ONE PATIENT. THE CUSTOMER INDICATED THE UNDILUTED SAMPLE (B)(6) GENERATED AN INITIAL RESULT OF >30 NG/ML AND DILUTED 1:2 GENERATED 9.8 NG/ML. THE SAMPLE WAS RETESTED AND UNDILUTED GENERATED >30 NG/ML AND DILUTED 1:2 GENERATED 12.83 NG/ML. THE CUSTOMER FURTHER REPORTED A SECOND TECHNICIAN SETUP AND RAN THE SAMPLE OBTAINING AN UNDILUTED RESULT OF >30 NG/ML AND DILUTED 1:2 GENERATED 33.86 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283278 ↗
• MalfunctionAug 26, 2016High Test Results; High Test Results

  THE CUSTOMER STATED THAT PATIENTS BEING TREATED WITH EVEROLIMUS TEST POSITIVE FOR SIROLIMUS ON THE ARCHITECT ANALYZER. ON (B)(6) 2016 A PATIENT BEING TREATED WITH EVEROLIMUS GENERATED A POSITIVE SIROLIMUS RESULT BY ARCHITECT, BUT A RESULT OF <0.9NG/ML ON THE UPLC MASS SPEC. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5906437 ↗