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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS LH

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 Class 2 Device Recall VIDAS LHsee related information
Date Initiated by FirmMarch 01, 2018
Create DateJuly 31, 2018
Recall Status1 Terminated 3 on December 09, 2025
Recall NumberZ-2588-2018
Recall Event ID 80087
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVIDAS 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)
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)
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact
919-620-2000
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionbioMerieux 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 CustomerService-ImmunoMolecular@biomerieux.com.
Quantity in Commerce5,429 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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