FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Tiger Medical Lands Untitled Letter for Failing to Restrict Sales to Doctors

June 13, 2018
A A

Tiger Medical received an untitled letter from the FDA for failing to comply with requirements that its Alere Determine HIV test kit only be sold to medical facilities or by prescription.

The FDA approved the test kit in 2013 under the condition that the device only be sold and distributed on the prescription or other order of a doctor or clinical laboratory that has “an adequate quality assurance program, including planned and systematic activities that provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional material.”

CBER’s Office of Compliance and Biologics Quality said the company failed to restrict its sales of the devices. The company’s website contained a note informing readers of the purchasing restrictions, but it sold and distributed them with no such restrictions.

View today's stories