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Terminated

VIDAS Testosterone, Ref 30418

FDA Recall Z-2339-2017 · Posted 2017-06-29

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeCDZ
Date Initiated2017-05-15
Date Terminated2020-06-11
Product Quantity742

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.

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.

Root Cause

Under Investigation by firm

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021326VIDAS TESTOSTERONE (TES), MODEL 30 418bioMerieux, Inc. · 2002-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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