ARCHITECT 2K46-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740003432), received between Sep 20, 2019 and Sep 20, 2019 — 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 20, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED ARCHITECT ANTI-TG AND ANTI-TPO RESULTS ON ONE PATIENT DIAGNOSED WITH HASHIMOTO'S THYROIDITIS. RESULTS PROVIDED: ANTI-TPO = 263.3 IU/ML (REF RANGE: <5.61 IU/ML); ANTI-TG = 622.1 IU/ML (REFERENCE RANGE: <4.11 IU/ML). ADDITIONAL TESTING PROVIDED: TSH = 2.192 MIU/ML (REFERENCE RANGE: 0.35-4.94 MIU/ML); T4 = 76.8 NMOL/L (REFERENCE RANGE: 62.68-150.84 NMOL/L); FT4 = 10.1 PMOL/L (REFERENCE RANGE: 9.01-19.05 PMOL/L); T3 = 1.32 NMOL/L (REFERENCE RANGE: 0.89-2.44 NMOL/L); FT3 = 3.95 PMOL/L (REFERENCE RANGE: 2.63-5.70 PMOL/L). THERE WAS NO INFORMATION AS TO THE IMPACT OF PATIENT HEALTH REPORTED. CUSTOMER REPORTED INCORRECT TREATMENT WAS PROVIDED FOR THE LAST SIX MONTHS FROM INITIAL TESTING. REQUESTED FURTHER CLARIFICATION FROM CUSTOMER REGARDING THIS ISSUE. TO BE CONSERVATIVE, WILL MAKE TICKET AN ADVERSE EVENT PENDING FURTHER INFORMATION FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100662 ↗