Recall Z-2339-2017— bioMerieux, Inc.

Name: FDA recall Z-2339-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-15

Class II · Terminated

Class II FDA medical device recall by bioMerieux, Inc., initiated 2017-05-15, terminated 2020-06-11. It names one FDA 510(k) clearance: K021326. Product: VIDAS Testosterone, Ref 30418. Reason: Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone..

Recalling firm: bioMerieux, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Terminated: 2020-06-11
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K021326 — VIDAS TESTOSTERONE (TES), MODEL 30 418bioMerieux, Inc.·cleared 2002-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.