Recall Z-2339-2017 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
bioMerieux, Inc.
VIDAS Testosterone, Ref 30418
| Date | Jun 29, 2017 (initiated May 15, 2017) |
| Status | Terminated |
| Reason | Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 742 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021326 | VIDAS TESTOSTERONE (TES), MODEL 30 418 bioMerieux, Inc., Jul 18, 2002 |