ARCHITECT 7D71-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740012946), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTS THAT ONE PATIENT (BEING TREATED FOR HYPERCALCEMIA AND RECEIVING CALCITONIN / HEMOFILTERED / 24 HOURS) SAMPLE GENERATED THE FOLLOWING CLIN CHEM PHOSPHORUS ASSAY RESULTS ON AN ARCHITECT C8000 ANALYZER: (B)(6): 3.87, 2.76, 3.27 AND 2.52 MMOL/L. THE SAMPLE WAS DRAWN WITH A HEPARIN COLLECTION TUBE. AN ADDITIONAL SAMPLE WAS DRAWN ON THIS PATIENT LATER IN THE DAY ((B)(6)) AND GENERATED RESULTS IN THE RANGE OF 1.35-1.83 MMOL/L (N=13) ALSO DRAWN IN A HEPARIN COLLECTION TUBE. THE CUSTOMER THEN RAN A SAMPLE FROM THIS SAME PATIENT THAT WAS DRAWN IN A RED TOP COLLECTION TUBE ((B)(6)). THIS SAMPLE GENERATED RESULTS IN THE RANGE OF 0.98-1.27 MMOL/L (N=10). THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 0.74-1.52 MMOL/L. THE PATIENT IS IN RECOVERY. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839718 ↗