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).
FDA Recall Z-2809-2015 · Posted 2015-09-23
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeOUG
Date Initiated2015-07-17
Date Terminated2018-01-04
Product Quantity2,456 units total (1,034 units total)
Reason for Recall
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.
Firm Action
An Urgent Medical Device Recall Letter dated 7/17/2015 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11. 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. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.