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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 Recall
NucliSens EasyQ Enterovirus serotype 68 ref.200300 v1.1
see related information
Date Posted July 06, 2011
Recall Status1 Terminated on October 06, 2011
Recall Number Z-2740-2011
Recall Event ID 58792
Premarket Notification
510(K) Number
K093383 
Product Classification Real Time Nucleic Acid Amplification System - Product Code OOI
Product NucliSens 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, North Carolina 27712-9402
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. 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
DESIGN: Device Design
Action BioMerieux 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 Commerce 42 kits
Distribution (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = BIOMERIEUX, INC.
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