ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III 10283344Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414553160), received between Jun 7, 2018 and Feb 10, 2025 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K083386); 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.

• MalfunctionFeb 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES GAVE FALSELY ELEVATED CALCIUM (CA_2C) TEST RESULTS FROM AN ADVIA CHEMISTRY XPT SYSTEM. THE FALSELY ELEVATED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEM. THE REPEAT RESULTS WERE LOWER, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347427 ↗
• MalfunctionJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT FALSELY LOW RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT SYSTEM WHEN USING CALCIUM_2 CONCENTRATED ASSAY (CA_2C) REAGENT LOT 424014. THE 4 PATIENT SAMPLES WERE REPEATED AGAIN ON THE SAME INSTRUMENT AND THE RESULTS WERE ACCEPTABLE. THE INITIAL FALSELY LOW RESULTS FOR THE 4 PATIENTS WERE REPORTED TO THE PHYSICIAN(S), AND NOT QUESTIONED. THE CORRECTED REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW RESULTS OBTAINED FOR THE CA_2 ASSAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579689 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083386. One submission often covers many models, so check the product and lot details in each record.

• Z-0928-2022 · Feb 9, 2022 · Open, Classified
  Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644