ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated 10283346Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414553184), received between Apr 2, 2018 and Apr 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (1 report).

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.

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.

• MalfunctionApr 2, 2018Device Issue; Device Issue

  DISCORDANT CREATININE (CRE_2C) TEST RESULTS WERE OBTAINED ON MULTIPLE SAMPLES ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME ADVIA CHEMISTRY XPT INSTRUMENT AND CORRECTED REPORTS WERE PROVIDED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREATININE TEST RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7389053 ↗

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