bioMerieux, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2339-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

VIDAS Testosterone, Ref 30418

Product Classification:

Class II

Date Initiated: May 15, 2017

Date Posted: July 19, 2017

Recall Number: Z-2339-2017

Event ID: 77292

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.

Status: Terminated

Product Quantity: 742

Code Information:

Lots 1004878310 & 1005001080

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated