Cl II Beckman Coulter MicroScan LabPro

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

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.