Z-2339-2017 Class II Terminated
FDA device recall Z-2339-2017 was initiated by bioMerieux, Inc. on May 15, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 11, 2020). Affected quantity: 742.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- June 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 742
Product Description
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 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
Code Information
Lots 1004878310 & 1005001080