FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: VIDAS Testosterone, Ref 30418
- Recall number
- Z-2339-2017
- Recalling firm
- bioMerieux, Inc.
- Product
- VIDAS Testosterone, Ref 30418
- Status
- Terminated
- Initiated
- 2017-05-15
- Posted
- 2017-06-29
- Terminated
- 2020-06-11
- 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
- Lot, serial or model codes
- Lots 1004878310 & 1005001080
- 510(k) numbers
- ["K021326"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28