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Beckman Coulter Inc. recalls MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agen
Recalled December 21, 2016 · FDA recall Z-0768-2017 · Beckman Coulter
Hazard
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. · FDA Class II
Units
131 units total (130 units in US)
Sold at
Worldwide Distribution -- United States and Mexico.
Description
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.
Product
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →