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Beckman Coulter Inc. recalls MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to ma
Recalled September 30, 2015 · FDA recall Z-2809-2015 · Beckman Coulter
Hazard
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. · FDA Class II
Units
2,456 units total (1,034 units total)
Sold at
Worldwide distribution: United States (including Puerto Rico), Bahamas, Belgium, Canada, Chile, China, Colombia, France, French Guiana, Germany, Greece, Guadeloupe, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Turkey, , US Virgin Islands, and Northern Mariana Islands, Uruguay.
Description
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.
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).
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →