NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
This recall has been terminated (originally issued July 6, 2011).
- Company
- Biomerieux, Inc.
- Recall Initiated
- May 10, 2011
- Posted
- July 6, 2011
- Terminated
- October 6, 2011
- Recall Number
- Z-2740-2011
- Quantity
- 42 kits
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
Distribution
(USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
Lot / Code Info
Catalog number: 200300, Lot number: 10042001, 9081001, 9112403, 9030902 and 9030901.
Root Cause
Device Design
Action Taken
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.