# FDA recall Z-2588-2018

> **bioMerieux, Inc.** · Class II · device recall initiated 2018-03-01.

## 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)

## 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

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.

## Key facts

- **Recall number:** Z-2588-2018
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-01
- **Report date:** 2018-08-08
- **Termination date:** 2025-12-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2018

## Citation

> AI Analytics. FDA recall Z-2588-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2588-2018. Source: US FDA. Licensed CC0.

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