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.
FDA Recall Z-1040-2017 · Posted 2017-01-18
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2016-12-21
Date Terminated2017-05-17
Product Quantity4 units
Reason for Recall
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Firm Action
The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification.
If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to MD only.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.