FDA Device recall Z-2339-2017
VIDAS Testosterone, Ref 30418
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of VIDAS Testosterone, Ref 30418 by Biomerieux, citing complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testostero….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2339-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-15 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | AR, CA, CO, GA, IA, IL, MI, MN, MT, NY, OK, TN, TX, WY |
Product
VIDAS Testosterone, Ref 30418
Reason
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Identifiers
| code_info | Lots 1004878310 & 1005001080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2339-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.