Device product
VIDAS Testosterone, Ref 30418
Z-2339-2017
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 77292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 742
- Official record key
device-enforcement:Z-2339-2017
Official wording
Reason: Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
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
Derived failure modes
-
Unknown
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.