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U.S. Department of Health and Human Services

Class 2 Device Recall MICroSTREP plus 1

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  Class 2 Device Recall MICroSTREP plus 1 see related information
Date Initiated by Firm September 10, 2015
Date Posted October 07, 2015
Recall Status1 Terminated 3 on January 22, 2016
Recall Number Z-0108-2016
Recall Event ID 72176
510(K)Number K020626  K062927  K091949  K062773  
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
Product MICroSTREP plus 1 Panel, Part No. B1027-201

Product Usage:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Code Information 2016-01-27  2016-02-27  2016-03-26  2016-04-02  2016-04-14  2016-05-01  2016-05-15  2016-06-12  
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 MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
FDA Determined
Cause 2		 Equipment maintenance
Action Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.
Quantity in Commerce 5138 units total (4,360 units in US)
Distribution Worldwide Distribution - US Nationwide and the countries of Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and 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.
510(K) Database 510(K)s with Product Code = LTT and Original Applicant = DADE BEHRING, INC.
510(K)s with Product Code = LTT and Original Applicant = DADE MICROSCAN, INC.
510(K)s with Product Code = LTT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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