MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent s

FDA device recall Z-0768-2017 · posted 2016-12-15 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.

Action taken

An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support representative: http://www.beckmancoulter.com or call 1-800-677-7226, option 1 in the United States.

Root cause

Device Design

Status

Terminated

Product code

OUG

Quantity affected

131 units total (130 units in US)

Distribution

Worldwide Distribution -- United States and Mexico.

Date initiated

2016-10-25

Date posted

2016-12-15

Date terminated

2017-05-01

Location

Brea, CA