Company: Beckman Coulter Inc.
Date of Enforcement Report 12/21/2016
Class lI:
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.
Recall Number Z-0768-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc. Brea, CA.on 10/25/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
131 units (130 in US)
DISTRIBUTION
Nationwide and Mexico
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