FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as tests for Ebola infection.
Risk: False test results may be life-threatening and may put consumers and others at risk of getting Ebola.
Customers should stop using the test kits and return them to LuSys Laboratories.
Report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178