NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
FDA Recall Z-2740-2011 · Posted 2011-07-06
Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeOOI
Date Initiated2011-05-10
Date Terminated2011-10-06
Product Quantity42 kits
Reason for Recall
The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
Firm 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.
Root Cause
Device Design
Distribution Pattern
(USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.