Recall Z-2740-2011 ยท OOI Real Time Nucleic Acid Amplification System
bioMerieux, Inc.
NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
| Date | Jul 6, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples. |
| 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) 68 |
| Quantity | 42 kits |
| Distribution | (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG bioMerieux, Inc., Jul 6, 2010 |