FDA recall Z-2339-2017

Product

VIDAS Testosterone, Ref 30418

Reason for recall

Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-05-15

Report date

2017-07-19

Termination date

2020-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2017