Company: Beckman Coulter Inc.
Date of Enforcement Report 9/30/2015
Class lI:
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA on 7/17/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,456 units total (1,034 units total)
DISTRIBUTION
Worldwide
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