FDA-Device2017-07-19Class II
VIDAS Testosterone, Ref 30418
bioMerieux, Inc.
Hazard
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Sold states
AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine
Affected count
742
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VIDAS Testosterone, Ref 30418
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief