Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0768-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2016-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0768-2017
Date of alert
2016-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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