AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open

FDA device recall Z-0056-2013 · posted 2012-10-12 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JQW

Quantity affected

468 units total (51 units in US)

Distribution

Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Isr

Date initiated

2012-04-11

Date posted

2012-10-12

Date terminated

2013-02-11

Location

Brea, CA