Z-2588-2018Class II

VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for...

Name: Z-2588-2018 VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for...
Creator: bioMerieux, Inc.
Published: 2018-03-01
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-03-01 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the... on 2018-03-01. FDA classified it as Class II and gives the reason as "Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2588-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-01
Posted: 2018-07-31
Terminated: 2025-12-09
Recalling firm: bioMerieux, Inc.
Product: VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: bioMerieux notified customers on about 03/01/2018, via letter. Instructions included to distribute the recall information to all appropriate personnel in the laboratory, forward the information to individuals to which the product many have been transferred to, destroy any impacted lots on site, and complete and return the Acknowledgement Form. Questions and concerns can be directed to local bioMerieux Customer Service representatives or for Clinical Technical Support Center by email at [email protected].
Quantity in commerce: 5,429 units
Distribution: Worldwide Distribution - US Nationwide in the state of Arizona and North Carolina. Distributed internationally to Algeria, Algeria, Angola, Argentina, Bahrain, Bangladesh, Belarus, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Colombia, Congo, Costa Rica, Cote d'Ivoire, Czech Republic, Djibouti, Dutch Antilles, Ecuador, Egypt, Estonia, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Mali, Mauretania, Mexico, Morocco, Mozambique, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, Republic of Congo, Romania, Russia, Saudi Arabia, Senegal, Serbia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, Uruguay, United Arab Emirates.
Product codes and lots: Reference No. 30406-01, Lot No. 1006041520 (Exp. Date 10/06/2018); Reference No. 30406, Lot No. (Exp. Date): 1005940920 (08/06/2018), 1006041540 (10/06/2018), 1006212740 (12/21/2018), 1006274770 (01/29/2019)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2588-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-31

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)