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
- Company
- Medica Corporation
- Recall Initiated
- March 29, 2010
- Posted
- October 18, 2010
- Terminated
- June 7, 2011
- Recall Number
- Z-0078-2011
- Quantity
- 14,926
- Firm Location
- Bedford, MA
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
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.
Lot / Code Info
Lot Numbers: 2009/A2810, 2009/A2910, 2009/A3010, 2010/A2001, 2010/A21 01, 2010/A1901, 2009/A0211, 2009/A0311
Root Cause
Other
Action Taken
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.