—#155630

Product

VIDAS Testosterone, Ref 30418

FDA product code: CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K021326
Affected lot / code info: Lots 1004878310 & 1005001080

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2017-05-15
Posted by FDA: 2017-06-29
Terminated: 2020-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.