ARCHITECT 7D71-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740012953), received between May 3, 2017 and May 3, 2017 — 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.

• MalfunctionMay 3, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CLINICAL CHEMISTRY PHOSPHORUS RESULTS FOR FIVE PATIENTS. THE CUSTOMER INDICATED THEY WERE GENERATING RESULTS OF <0.7 MG/DL FOR EACH PATIENT, THE RETEST WAS WITHIN RANGE. INITIAL AND RETEST RESULTS FOR FOUR OF THE FIVE PATIENTS WAS PROVIDED AS FOLLOWS: ON (B)(6) 2016: INITIAL <0.7 MG/DL, RETESTED ON (B)(6) 2016 ON A SECOND ANALYZER: 2.0 MG/DL SID (B)(6) INITIAL <0.7, RETEST 1.8 MG/DL; SID (B)(6) INITIAL <0.7, RETEST 2.0 MG/DL; SID (B)(6) INITIAL <0.7, RETEST 2.0 MG/DL. (CUSTOMER NORMAL PATIENT RANGE 2.3 - 4.7 MG/DL). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541452 ↗