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U.S. Department of Health and Human Services

Class 2 Device Recall EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer

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 Class 2 Recall
EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer
see related information
Date Posted October 18, 2010
Recall Status1 Terminated on June 07, 2011
Recall Number Z-0078-2011
Recall Event ID 55150
Premarket Notification
510(K) Number
K070057 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 10991
Code Information Lot Numbers: 2009/A2810, 2009/A2910, 2009/A3010, 2010/A2001, 2010/A21 01, 2010/A1901, 2009/A0211, 2009/A0311
Recalling Firm/
Manufacturer
Medica Corporation
5 Oak Park Dr
Bedford, Massachusetts 01730
For Additional Information Contact Photios Makris
781-275-4892
Manufacturer Reason
for Recall
Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Medica issued an Urgent Product Recall letter dated March 29, 2010 to customers. Users were requested to cease using and discard the affected product, and complete and return a Response Form in order to obtain replacement product. Customers can contact Medica Technical Support at 877-777-5895.
Quantity in Commerce 14,926
Distribution Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.
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 = JJE and Original Applicant = MEDICA CORP.
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