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Recall Observatory FDA recall evidence

Device product

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.

Z-1040-2017

December 21, 2016

Class III

Product summary

Firm
Beckman Coulter Inc.
Event
Event 76054
Status
Terminated
Classification
Class III
Quantity
4 units
Official record key
device-enforcement:Z-1040-2017

Official wording

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

Code information: ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

Distribution pattern: US Distribution to MD only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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