Beckman Coulter Inc. recalls MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent…

Recall date

October 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0768-2017

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution -- United States and Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.