EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits:
FDA device recall Z-0078-2011 · posted 2010-10-18 · Terminated
Recall details
- Recalling firm
- Medica Corporation
- 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
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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.
- Date initiated
- 2010-03-29
- Date posted
- 2010-10-18
- Date terminated
- 2011-06-07
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT (K072249) | Medica Corp. | 2008-02-20 |
| EASYRA CLINICAL CHEMISTRY ANALYZER (K070057) | Medica Corp. | 2007-08-30 |