Skip to content

Power LinkRecalls & reported problems

Beckman Coulter, Inc. · Power Link · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590583996), received between Oct 4, 2022 and Oct 4, 2022 — classified as 1 injury.

2 other recalls 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED AN INJURY WHILE OPERATING THE POWER LINK SYSTEM. THE CUSTOMER WAS PERFORMING MAINTENANCE ON THEIR SYSTEM, AND WHILE REMOVING THE SAMPLE FROM THE GRIPPER, THE CUSTOMER CUT THE FINGER ON THE POWERLINK INLET METAL PLATE. IT WAS KNOWN THAT THE CUSTOMER DID NOT WEAR GLOVES AT THE TIME OF THE INCIDENT. DUE TO SERUM RESIDUE SEEN ON THE METAL PLATE, CUSTOMER FOLLOWED THEIR OCCUPATIONAL HEALTH NEEDLESTICK GUIDELINES AND SOUGH MEDICAL ATTENTION. THE CUSTOMER RECEIVED FIRST AID KIT FOR LOCAL DRESSING. CUSTOMER ALSO RECEIVED HEPATITIS B SHOT VACCINATION. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. AS OF (B)(6) 2022, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15540320 ↗

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-0117-2022 · Jul 28, 2021 · Open, Classified
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
  • Z-0046-2018 · Aug 3, 2017 · Terminated
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

Other Analyzer, Chemistry (Photometric, Discrete), For Clinical Use devices

All Analyzer, Chemistry (Photometric, Discrete), For Clinical Use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.