PlainRecalls
FDA Devices Low Class III Terminated

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 label

Reported: January 25, 2017 Initiated: December 21, 2016 #Z-1040-2017

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.

Reason for Recall

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

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
4 units
Distribution
US Distribution to MD only.
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 4 units.
Why was this product recalled? ▼
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Low. Recall number: Z-1040-2017.

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