Cl II Beckman Coulter MicroScan LabPro

Company: Beckman Coulter Inc.
Date of Enforcement Report 9/30/2015
Class lI:


MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
Recall Number Z-2809-2015

Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

Beckman Coulter Inc., Brea, CA on 7/17/2015. Voluntary: Firm Initiated recall is ongoing.

2,456 units total (1,034 units total)



About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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