—#112702

Product

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.

FDA product code: JQW — Station, Pipetting And Diluting, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All Serial Numbers

Why it was recalled

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom

Timeline

Recall initiated: 2012-04-11
Posted by FDA: 2012-10-12
Terminated: 2013-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.