NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
FDA device recall Z-2740-2011 · posted 2011-07-06 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OOI
- Quantity affected
- 42 kits
- Distribution
- (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
- Date initiated
- 2011-05-10
- Date posted
- 2011-07-06
- Date terminated
- 2011-10-06
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383) | bioMerieux, Inc. | 2010-07-06 |