Z-2740-2011

NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

Name: Z-2740-2011 NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
Creator: bioMerieux, Inc.
Published: 2011-05-10
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2011-05-10 / Terminated / root cause: design

FDA source

bioMerieux, Inc. began a recall of NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test on 2011-05-10. The reason FDA records is "The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2740-2011
Status: Terminated
Initiated: 2011-05-10
Posted: 2011-07-06
Terminated: 2011-10-06
Recalling firm: bioMerieux, Inc.
Product: NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Catalog number: 200300, Lot number: 10042001, 9081001, 9112403, 9030902 and 9030901.

Product code OOI

K093383Class IINuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens MinimagbioMerieux, Inc. / cleared 2010-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)