Reported Nov 27, 2019 · Ongoing

AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with…

Beckman Coulter Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • AutoMate 1250
  • Sorter with Aliquot Module - UDI
    • 15099590364106
    • Model #ODL25125 Automate 2550
    • High
  • Speed Sorter with Aliquot Module - UDI
    • 15099590364083
    • Model #ODL25255
Lot codes and dates
  • All units containing software Version(s) 4.1.1 and up
Amount recalled
83 automate systems

Where it was sold

Why it was recalled

Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

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