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

Z-2588-2018 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
August 8, 2018
Initiation Date
March 1, 2018
Termination Date
December 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)

Other recalls by bioMerieux, Inc.

  • Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ce (January 5, 2026)
  • Z-2671-2025 Class II — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs0 (June 26, 2025)
  • Z-1464-2024 Class I — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial suscep (March 14, 2024)
  • Z-1201-2023 Class II — MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connec (February 6, 2023)
  • Z-0795-2023 Class II — VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 (November 9, 2022)
  • Z-0856-2023 Class II — VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 (November 9, 2022)
  • Z-0791-2023 Class II — VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 (November 9, 2022)
  • Z-0871-2023 Class II — PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR (November 9, 2022)
  • Z-0824-2023 Class II — ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 (November 9, 2022)
  • Z-0852-2023 Class II — ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 (November 9, 2022)