ARCHITECT 7D71-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740161736), received between Feb 24, 2022 and Feb 13, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED PHOSPHORUS RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLE RESULTS: (CUSTOMER PROVIDED NORMAL RANGE 2.5-4.5 MG/DL) (B)(6) INITIAL RESULT = <0.7 MG/DL, REPEAT RESULT ON (C8000) = 2.1 MG/DL. (B)(6) INITIAL RESULT = 1.3 MG/DL, REPEAT RESULT ON (C8000) = 2.8 MG/DL. (B)(6) INITIAL RESULT = 1.2 MG/DL, REPEAT RESULT ON (C8000) = 2.7 MG/DL. (B)(6) INITIAL RESULT = 0.9 MG/DL, REPEAT RESULT ON (C8000) = 2.3 MG/DL. (B)(6) INITIAL RESULT = 1.7 MG/DL, REPEAT RESULT ON (C8000) = 3.2 MG/DL. (B)(6) INITIAL RESULT = <0.7 MG/DL, REPEAT RESULT ON (C8000) = 1.8 MG/DL. (B)(6) INITIAL RESULT = 1.7 MG/DL, REPEAT RESULT ON (C8000) = 3.3 MG/DL. (B)(6) INITIAL RESULT = 1.2 MG/DL, REPEAT RESULT ON (C8000) = 2.6 MG/DL. (B)(6) INITIAL RESULT = 1.6 MG/DL, REPEAT RESULT ON (C8000) = 3.0 MG/DL. (B)(6) INITIAL RESULT = 0.8 MG/DL, REPEAT RESULT ON (C8000) = 2.1 MG/DL. THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF PATIENTS WERE PROVIDED AN UNSPECIFIED TREATMENT BASED ON RESULTS AND IS NOT AWARE OF ANY ADVERSE EFFECT ON THE PATIENTS. THE RESULTS WERE THEN REPEATED ON THE ARCHITECT C8000 AND THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694258 ↗
• MalfunctionFeb 24, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT DISCREPANT ARCHITECT PHOSPHORUS RESULTS WERE GENERATED FOR PATIENT SAMPLE ID (B)(6). AN INITIAL RESULT OF 0.94 MMOL/L WAS GENERATED (WITHIN NORMAL RANGE) AND THE CUSTOMER DECIDED TO RETEST THE SAMPLE WHICH RETESTED AT <0.21 MMOL/L (BELOW NORMAL RANGE) USING TWO DIFFERENT REAGENT LOTS. THE CUSTOMER USES SAMPLE COLLECTION TUBES WITH A SEPARATING GEL. IT IS SUSPECTED THAT THE SAMPLE PROBE POSSIBLY WENT INTO THE GEL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592656 ↗