VIDAS Testosterone, Ref 30418
FDA device recall Z-2339-2017 · posted 2017-06-29 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CDZ
- Quantity affected
- 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
- Date initiated
- 2017-05-15
- Date posted
- 2017-06-29
- Date terminated
- 2020-06-11
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326) | bioMerieux, Inc. | 2002-07-18 |