VIDAS Testosterone — Class II medical device recall Z-2339-2017
Terminated recall by bioMerieux, Inc., reported 2017-07-19, distributed in AR, CA, CO, GA, IA, IL, MI, MN…. Complaints were received from customers observing falsely overestimate results or external quality control hig
| Recall number | Z-2339-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2017-05-15 |
| Classified | 2017-07-11 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2020-06-11 |
| Distributed | AR, CA, CO, GA, IA, IL, MI, MN, MT, NY, OK, TN, TX, WY |
| Countries outside the US | CR, FR, HK, JO, LK, NI, SE, SV, UA |
| Quantity | 742 |
| Lot numbers | 1004878310, 1005001080 |
| Model numbers | 30418 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2339-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.