Atellica CH Iron_2 11097601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414596402), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K991576); 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.

Recalls naming this device

1. Jun 28, 2022Class IIOpen, Classified

   Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

   Z-1498-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionFeb 23, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY DEPRESSED, MICROALBUMIN_2 (ALB_2) RESULT ON A PATIENT SAMPLE WHEN PERFORMING REPEAT TESTING ON AN ATELLICA CH 930 ANALYZER. THE CUSTOMER DID NOT REPORT THE REPEAT RESULT AND NOTED THAT THE INITIAL RESULT WAS CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED MICROALBUMIN_2 (ALB_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991576. One submission often covers many models, so check the product and lot details in each record.

• Z-2062-2018 · Mar 27, 2018 · Terminated
  ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
• Z-1658-2016 · Mar 17, 2016 · Terminated
  Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated