Atellica IM ThCG 11206261Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414293776), received between Jan 31, 2025 and Jan 31, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM TOTAL HCG (THCG), LOT 360, PATIENT SERUM SAMPLE RESULT THAT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS RETESTED ON A DIFFERENT ATELLICA IM ANALYZER IN DUPLICATE, AND THE RESULTS WERE LOWER AS EXPECTED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282990 ↗