—#152055

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.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: RegulatoryAgencyInquiries@beckman.com.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: US Distribution to MD only.

Timeline

Recall initiated: 2016-12-21
Posted by FDA: 2017-01-18
Terminated: 2017-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.