Z-2339-2017Class II

VIDAS Testosterone, Ref 30418

Name: Z-2339-2017 VIDAS Testosterone, Ref 30418
Creator: bioMerieux, Inc.
Published: 2017-05-15
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-05-15 / Terminated

FDA source

bioMerieux, Inc. began a recall of VIDAS Testosterone, Ref 30418 on 2017-05-15. FDA classified it as Class II and gives the reason as "Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2339-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Posted: 2017-06-29
Terminated: 2020-06-11
Recalling firm: bioMerieux, Inc.
Product: VIDAS Testosterone, Ref 30418
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
FDA 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 in commerce: 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
Product codes and lots: Lots 1004878310 & 1005001080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2339-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2339-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11

Product code CDZ

K021326Class IVidas Testosterone (Tes), Model 30 418bioMerieux, Inc. / cleared 2002-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)