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Automate 2500 Family AutoMate 2550Recalls & reported problems

Beckman Coulter, Inc. · AutoMate2550 – High Speed Sorter with Aliquot Module · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590364083), received between Jul 23, 2018 and Mar 18, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Mechanical Jam1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Crushing Injury1

Recent adverse event reports

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

  • InjuryMar 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT THE SORTING DRIVE OF THEIR AUTOMATE 2550 IS ALIQUOTING THE WRONG TUBE AND STORING THE CORRECT TUBE WHICH RESULTED IN THE RELEASE OF FALSE TROPONIN PATIENT RESULTS. THE CUSTOMER REPORTED THAT THERE WAS A CHANGE IN PATIENT TREATMENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16569801 ↗
  • InjuryJul 23, 2018Mechanical Jam; Mechanical Jam

    ON (B)(6) 2018, A USER INCORRECTLY TRIED TO REMOVE TUBES THAT WERE BLOCKED/JAMMED FROM INSIDE THE AUTOMATE 2550 LAB INSTRUMENT. THE USER'S THUMB BECAME "BLOCKED" BY THE ROLLER RESULTING IN A BRUISED THUMB. THE USER RECEIVED A MEDICAL REVIEW AND PRESCRIPTION ANTI-INFLAMMATORY TREATMENT.

    Patient problems: Crushing Injury

    MAUDE report 7710877 ↗

Other Calculator/Data Processing Module, For Clinical Use devices

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Sources and updates

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