VIDAS Testosterone, Ref 30418
- Company
- Biomerieux, Inc.
- Recall Initiated
- May 15, 2017
- Posted
- June 29, 2017
- Terminated
- June 11, 2020
- Recall Number
- Z-2339-2017
- Quantity
- 742
- Firm Location
- Durham, NC
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
Lot / Code Info
Lots 1004878310 & 1005001080
Root Cause
Under Investigation by firm
Action Taken
An Urgent Product Safety Notice was sent on 5/15/2017 to consignees. The Notice requested that they discontinue use and discard any remaining inventory of the product, and to identify any possible falsely over estimated results and determine appropriate actions if relevant. The Notice also included a response form to be returned to Biomerieux.