Recalls / —
—#100303
Product
NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
- FDA product code
- OOI — Real Time Nucleic Acid Amplification System
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K093383
- Affected lot / code info
- Catalog number: 200300, Lot number: 10042001, 9081001, 9112403, 9030902 and 9030901.
Why it was recalled
The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- Distribution pattern
- (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA
Timeline
- Recall initiated
- 2011-05-10
- Posted by FDA
- 2011-07-06
- Terminated
- 2011-10-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.