LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteri

Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction Letter dated November 16, 2016, to all affected customers via UPS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until Roche provides updated Instructions for Use to assist in result interpretation. If product was further distributed, ensure the Urgent Medical Device Correction letter is provided to that site. Also, customers were instructed to completed the attached fax form and fax it to 1-888-912-2188. For questions customers should call 1-800-526-1247.