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U.S. Department of Health and Human Services

Class 2 Device Recall BS200 Chemistry Analyzer

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  Class 2 Device Recall BS200 Chemistry Analyzer see related information
Date Initiated by Firm November 28, 2012
Date Posting Updated March 22, 2013
Recall Status1 Terminated 3 on June 12, 2013
Recall Number Z-0977-2013
Recall Event ID 64112
510(K)Number K072018  K022519  
Product Classification Hexokinase, glucose - Product Code CFR
Product BS-200 Chemistry Analyzer

Designed for clinical laboratory use.
Code Information Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
Recalling Firm/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Mr. Tony Li
800-288-2121 Ext. 2112
Manufacturer Reason
for Recall
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
FDA Determined
Cause 2
Device Design
Action Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.
Quantity in Commerce 3 units
Distribution Distributed in the states of NC and TX.
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 = CFR and Original Applicant = JAS Diagnostics, Inc.
510(K)s with Product Code = CFR and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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