FDA-Device2016-12-21Class II
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.
Beckman Coulter Inc.
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.
Sold states
Worldwide Distribution -- United States and Mexico.
Affected count
131 units total (130 units in US)
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2017Don't want to check this manually?
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