Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-1040-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

Product Classification:

Class III

Date Initiated: December 21, 2016

Date Posted: January 25, 2017

Recall Number: Z-1040-2017

Event ID: 76054

Reason for Recall:

Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

Status: Terminated

Product Quantity: 4 units

Code Information:

ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

Distribution Pattern:

US Distribution to MD only.

Voluntary or Mandated:

Voluntary: Firm initiated