Atellica IM CsA 10995548Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414598727), received between Jan 20, 2026 and Jan 20, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K071455); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Low Test Results

  THE CUSTOMER COMPLAINED OF LOW ATELLICA IM CYCLOSPORINE (CSA) LOT 055 PATIENT RESULTS. A DISCORDANT RESULT WAS IDENTIFIED WHERE A PATIENT SAMPLE TESTED ON (B)(6) 2025 WITH ATELLICA IM CSA RESULTED LOWER THAN A RESULT FROM AN ALTERNATE METHOD OBTAINED AT A DIFFERENT LAB. THERE ARE NO REPORTS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116830 ↗
• MalfunctionJan 20, 2026Low Test Results

  THE CUSTOMER REPORTED DISCORDANT (LOW) ATELLICA IM CYCLOSPORINE (CSA) LOT 055 PATIENT RESULTS. THE CUSTOMER PROVIDED DATA FOR 2 PATIENT SAMPLES TESTED ON (B)(6) 2026 WHERE THE INITIAL ATELLICA IM CSA WERE LOWER THAN RESULTS FROM AN ALTERNATE METHOD OBTAINED AT A DIFFERENT LAB. THERE ARE NO REPORTS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071455. One submission often covers many models, so check the product and lot details in each record.

• Z-1687-2018 · Jan 2, 2018 · Terminated
  ADVIA Centaur Cyclosporine