Power Processor Sample Handling SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590591960), received between Feb 28, 2017 and Mar 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K110413); 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.

Recalls naming this device

1. Jul 28, 2021Open, Classified

   Missing splash guard which may expose users to hazardous materials. .

   Z-0117-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED SUSTAINING AN IN INJURY TO HIS FINGER WHEN PERFORMING PREVENTATIVE MAINTENANCE ON THEIR POWER PROCESSOR BASIC TRACK ONE OUTLET. THE FSE INDICATED THAT WHILE LUBRICATING BELTS DURING A PM TASK, A SMALL METAL SLIVER SHAVING ENTERED THEIR FINGER. THE INJURY WAS NOT IMMEDIATELY REPORTED. THE FSE LATER SOUGHT MEDICAL ATTENTION DUE TO PAIN AND SWELLING IN THEIR RIGHT THUMB. THE FSE WAS REFERRED TO THE EMERGENCY ROOM (EM) WHERE THEY WERE ADMINISTERED A TETANUS SHOT AS A RESULT OF INJURY. THE FSE ALSO GOT AN X-RAY OF HIS FINGER. THE FSE CONFIRMED THE METAL SHAVING WAS GONE AFTER MEDICAL ATTENTION. NO WORK WAS MISSED DUE TO THIS INCIDENT, NO MEDICATIONS WERE PRESCRIBED. NO ADDITIONAL HARM WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 21684566 ↗
• InjuryFeb 28, 2017Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED TO BECKMAN COULTER THAT WHILE ATTEMPTING TO REMOVE A SAMPLE FROM THE POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULES, THE DECAPPER STRUCK THE CUSTOMER'S HAND AND PUNCTURED THE SKIN.

  Patient problems: Injury

  MAUDE report 6366500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110413. One submission often covers many models, so check the product and lot details in each record.

• Z-0046-2018 · Aug 3, 2017 · Terminated
  Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.