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bioMerieux, Inc. recalls VIDAS Testosterone, Ref 30418
Recalled July 19, 2017 · FDA recall Z-2339-2017 · bioMerieux
Hazard
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone. · FDA Class II
Units
742
Sold at
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
Description
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Product
VIDAS Testosterone, Ref 30418
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →