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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan LabPro Information Manager System

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  Class 2 Device Recall MicroScan LabPro Information Manager System see related information
Date Initiated by Firm July 17, 2015
Date Posted September 23, 2015
Recall Status1 Terminated 3 on January 04, 2018
Recall Number Z-2809-2015
Recall Event ID 71819
Product Classification Medical device data system - Product Code OUG
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).
Code Information Version 1.0 to Version 4.11
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Rula Melconian
714-961-4295
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by 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.
Quantity in Commerce 2,456 units total (1,034 units total)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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