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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 February 11, 2016
Create Date March 28, 2016
Recall Status1 Terminated 3 on January 04, 2018
Recall Number Z-1269-2016
Recall Event ID 73417
Product Classification Medical device data system - Product Code OUG
Product MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41

Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026.

Japan:
10638819 LabPro v4.11 Software Update Kit
10638820 LabPro v4.11 System Software
10805072 LabPro MBT Non-Connect Systems v4.30
10805073 LabPro MBT Connect Systems v4.30
Canada:
6000-0008 LabPro v4.41 Panel Update-06 Kit
6000-0026 LabPro Connect v4.41 Panel Update-06 Kit
10638823 LabPro v4.11 Software Update Kit
10638825 LabPro v4.11 System Software
10638824 LabPro v4.11 Software Update Kit
Europe:
10638824 LabPro v4.11 Software Update Kit
10638826 LabPro v4.11 System Software
USA:
10714149, LabPro v4.11 Software Update Kit
10714150 LabPro v4.11 System Software
10975000 ASM LabPro-MBT v4.40
10975001 ASM LabPro-MBT v4.40 for Connect
6000-0008 LabPro v4.41 Panel Update-06 Kit
6000-0026 LabPro Connect v4.41 Panel Update-06 Kit
ROW:
6000-0008 LabPro v4.41 Panel Update-06 Kit
10638823 LabPro v4.11 Software Update Kit
10638825 LabPro v4.11 System Software
10638824 LabPro v4.11 Software Update Kit
10638826 LabPro v4.11 System Software

Product Usage:
LabPro Data Management System is a Microsoft Windows based software program and is 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. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
Code Information not applicable
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		 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. 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 2,702 units total (1,032 units in US)
Distribution Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
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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