Home / Recalls / bioMerieux, Inc. / Z-2588-2018

Z-2588-2018 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

FDA device recall Z-2588-2018 was initiated by bioMerieux, Inc. on Mar 1, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 9, 2025). Affected quantity: 5,429 units.

Recall Details

Product Type: Devices
Report Date: Aug 8, 2018
Initiation Date: Mar 1, 2018
Termination Date: Dec 9, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,429 units

Product Description

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)

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.

Distribution Pattern

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.

Code Information

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)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2588-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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