AU OSR6178Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590010737), received between Jan 21, 2020 and Jan 21, 2020 — 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 (K924692); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 21, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF A FALSE LOW CREATININE RESULT FOR ONE (1) PATIENT SAMPLE ON THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULT WAS REPORTED OUTSIDE THE LAB. DUE TO THE FALSE LOW CREATININE PATIENT RESULT, THE PATIENT WAS SCANNED AND RECEIVED AN INTRAVENOUS INJECTION OF IODINE CONTRAST AGENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924692. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2013 · Dec 28, 2012 · Terminated
  Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzer