ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) 10341116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414513102), received between Jul 30, 2023 and Jul 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ADVIA 1800 CHEMISTRY CALCIUM_2 (CA_2) DISCORDANT LOW INITIAL RESULT COMPARED TO HIGHER RETEST RESULTS, THAT MATCHED WITH OTHER CLINICAL RESULTS OF THIS PATIENT. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE RETEST RESULTS WERE OBTAINED USING THE SAME SAMPLE TESTED ON DIFFERENT ON ADVIA 1800 CHEMISTRY SYSTEMS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421668 ↗

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