G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. For questions contact Randox Technical Services.