ARCHITECT 2K45-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740003388), received between Jul 10, 2019 and Jul 10, 2019 — classified as 1 injury.

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.

• InjuryJul 10, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A (B)(6) FEMALE PATIENT UNDERWENT A CAT SCAN WITH IV CONTRAST, AN ENTEROSCOPY, AND A GASTROSCOPY BASED ON FALSELY ELEVATED CA 19-9 AND CA125 RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER. RESULTS PROVIDED: SID (B)(6), (B)(6) 2019 CA 19-9 = >1200 U/ML / REFERENCE LAB = <37 U/ML; SID (B)(6), (B)(6) 2019 CA125 = 126.4 U/ML / REFERENCE LAB = <35 U/ML. THE PATIENT IS DOING WELL AND THERE WAS NO ADVERSE IMPACT TO THE PATIENTS HEALTH REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776748 ↗