VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quanti...
FDA Device Recall #Z-2588-2018 — Class II — March 1, 2018
Recall Summary
| Recall Number | Z-2588-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 1, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | bioMerieux, Inc. |
| Location | Durham, NC |
| Product Type | Devices |
| 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.
Lot / 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)
Other Recalls from bioMerieux, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2671-2025 | Class II | VITEK¿ 2 Gram-negative AST Test Kits (Cards) co... | Jun 26, 2025 |
| Z-1564-2022 | Class II | NUCLISENS easyMAG Magnetic Silica, REF 280133, ... | Jul 20, 2022 |
| Z-1640-2022 | Class II | VITEK 2 / MYLA VITEK 2 Software versions 8.0... | Jul 13, 2022 |
| Z-1059-2022 | Class II | VITEK 2 Systems and VITEK 2 with MYLA. | Mar 29, 2022 |
| Z-0742-2022 | Class II | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Feb 9, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.