Reported Dec 21, 2016 · Terminated
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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.
- Lot codes and dates
Software Version 4.42Part No. 6000-00506000-00516000-00526000-00536000-0054and 6000-0060
- Amount recalled
- 131 units total (130 units in US)
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.
This product could cause temporary or reversible health problems — stop using it.
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