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Terminated

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

FDA Recall Z-0078-2011 · Posted 2010-10-18

Recalling FirmMedica Corporation
Recall StatusTerminated
Product CodeJJE
Date Initiated2010-03-29
Date Terminated2011-06-07
Product Quantity14,926

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

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072249EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENTMedica Corp. · 2008-02-20K070057EASYRA CLINICAL CHEMISTRY ANALYZERMedica Corp. · 2007-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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