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U.S. Department of Health and Human Services

Class 2 Device Recall NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1

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 Class 2 Device Recall NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1see related information
Date Initiated by FirmMay 10, 2011
Date PostedJuly 06, 2011
Recall Status1 Terminated 3 on October 06, 2011
Recall NumberZ-2740-2011
Recall Event ID 58792
510(K)NumberK093383 
Product Classification Real Time Nucleic Acid Amplification System - Product Code OOI
ProductNucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
Code Information Catalog number: 200300, Lot number: 10042001, 9081001, 9112403, 9030902 and 9030901.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactMr. Benjamin Smith
314-731-8537
Manufacturer Reason
for Recall		The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
FDA Determined
Cause 2		Device Design
ActionBioMerieux Vitek, Inc. sent an "Urgent Product Correction Notice" letter on/about May 10, 2011. The letter included; a description of the product, problem, possible impact to the patient and recommendations. Recommendations included instructing customers to discontinue the use of the kit for the detection of Enterovirus 68 and Rhinovirus 87 serotypes and noted the corrected IFU will be available the first week of April 2011. An Acknowledgement form was attached to be returned via fax. For additional questions please contact your local BioMerieux Clinical Customer representative at (800) 682-2666, option 3, option 2.
Quantity in Commerce42 kits
Distribution(USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
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.
510(K) Database510(K)s with Product Code = OOI
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