Recall Z-1677-2015 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere Scarborough, Inc. dba Binax, Inc.
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for
| Date | May 26, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. |
| Root cause | Under Investigation by firm |
| Action | Alere sent an Urgent Medical Device Recall letter dated April 23, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop using the product and discard any unused product. Customers asked to complete and return the Verification form within 10 days to confirm receipt of the recall notification and to request credit. For questions about the information contained in the notification, contact Alere Technical Services, Monday through Friday, 8am to 8pm EST. Telephone: (855) 731-2288 or E-mail: t s.scr@alere.com. For |
| Quantity | 213 kits plus 3 - evaluation use only kits |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141520 | ALERE I INFLUENZA A & B Alere Scarborough, Inc D/B/A Binax, Inc., Jun 13, 2014 |