||October 12, 2012
||Terminated on February 11, 2013
|Recall Event ID
Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
||AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255.
The AutoMate 1200/2500 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 processes. 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 the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
||All Serial Numbers
|Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
|For Additional Information Contact
||Clair K. O'Donovan, Ph.D.
|The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.
|MISBRANDING: Labeling False and Misleading
||Beckman Coulter initiated an Urgent Product Correction letter dated April 11, 2012, with attached PCA Response Form to all customers who purchased the affected product. . The letter identified the product, the problem, and the action taken by the customer. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local Beckman Coulter representative. Customers with questions should call 714-993-5321.
For questions regarding this recall call 714-961-4941.
|Quantity in Commerce
||468 units total (51 units in US)
||Worldwide Distribution - USA (nationwide) and the following countries:
Korea, Republic of
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.