ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) 10316612Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414513096), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED (18-20% HIGHER) CALCIUM ARSENAZO (CA_2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. IT IS UNKNOWN WHICH REAGENT LOT WAS USED. THE CUSTOMER HAS DECLINED TO PROVIDE ANY PATIENT SAMPLE DATA TO SIEMENS. IT IS UNKNOWN IF THE SAMPLES WERE REPEATED AND IF THE INITIAL AND/OR REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CALCIUM ARSENAZO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481085 ↗

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