AU OSR6130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590010270), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K963424); 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 16, 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.

• InjuryApr 2, 2026Device Handling Problem

  THE CUSTOMER REPORTED AN OPERATOR SUSTAINED CUT INJURIES TO INDEX AND MIDDLE FINGERS WHEN ATTEMPTING REMOVE METAL SEAL FROM LIPASE REAGENT BOTTLE USING SHARP POINTED HEMOSTATS. THE CUSTOMER REQUIRED MEDICAL INTERVENTION DUE TO BLEEDING AND PAIN CAUSED BY THE INJURY. THE OPERATOR WAS EVALUATED BY MEDICAL PROFESSIONAL WHICH RESULTED IN CLEANING THE WOUND WITH WATER, DRESSING IT, AND PRESCRIPTION OF TOPICAL OINTMENT APPLICATION TO TREAT THE WOUND. THE OPERATOR MISSED TWO DAYS OF WORK DUE TO THE INJURY. THERE WAS NO REPORT OF DEATH ASSOCIATED TO THIS EVENT. NO ADDITIONAL HARM WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 24770263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963424. One submission often covers many models, so check the product and lot details in each record.

• Z-1023-2015 · Dec 15, 2014 · Terminated
  Beckman Coulter, Lipase Assay, Catalog No. OSR6X30