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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan LabPro Data Management System

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  Class 2 Device Recall MicroScan LabPro Data Management System see related information
Date Initiated by Firm October 25, 2016
Date Posted December 15, 2016
Recall Status1 Terminated 3 on May 01, 2017
Recall Number Z-0768-2017
Recall Event ID 75576
Product Classification Medical device data system - Product Code OUG
Product MicroScan LabPro Data Management System.

Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
Code Information Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.
FDA Determined
Cause 2		 Device Design
Action An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support representative: http://www.beckmancoulter.com or call 1-800-677-7226, option 1 in the United States.
Quantity in Commerce 131 units total (130 units in US)
Distribution Worldwide Distribution -- United States and Mexico.
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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