ADVIA® Chemistry IRON_2 Iron 2 Reagents 10377510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414561974), received between Jun 22, 2017 and Jun 22, 2017 — classified as 1 malfunction.

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

3 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. Aug 8, 2023Class IIOpen, Classified

   There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

   Z-2666-2023 · 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.

• MalfunctionJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBTAINED DISCORDANT, FALSELY LOW IRON_2 RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ADVIA 2400 INSTRUMENT, WHILE USING REAGENT KIT LOT # 393998. THE SAMPLES WERE REPEATED ON THE ALTERNATE ADVIA CHEMISTRY INSTRUMENTS, RESULTING HIGHER. THE INITIAL RESULTS FOR SAMPLE IDS (B)(6) WERE REPORTED TO THE PHYSICIAN(S). THE CORRECTED RESULTS FOR SAMPLE IDS (B)(6) WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH RESULTS WERE REPORTED FOR SAMPLE IDS (B)(6). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IRON_2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6661581 ↗

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-1498-2022 · Jun 28, 2022 · Open, Classified
  Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
• 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