• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BS200 Chemistry Analyzer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
BS200 Chemistry Analyzer
see related information
Date Posted March 22, 2013
Recall Status1 Terminated on June 12, 2013
Recall Number Z-0977-2013
Recall Event ID 64112
Premarket Notification
510(K) Numbers
K022519  K072018 
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, New Jersey 07430
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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
-
-