Recall Z-2095-2015 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere Scarborough, Inc. dba Binax, Inc.
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & 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
| Date | Jul 16, 2015 (initiated Jun 26, 2015) |
| Status | Terminated |
| Reason | Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit |
| Root cause | Process change control |
| Action | Alere sent a Urgent Medical Device Recall letter dated June 26, 2015, to all affected consignees. Customers were instructed to cease use and discard any unused pouched Sample Receivers and Transfer Cartridges contained in Alere" i Influenza A & B PN 425-024, Lot 0073853. Pouched Sample Receivers and Transfer Cartridges are identified in the kit as part number 425-431 lot number 074005 or 074108. Replacement Sample Receivers and Transfer Cartridges will be provided to the customer. Customers with questions were instructed to call Alere Technical Services at 855-731-2288 or email ts.scr@alere. |
| Quantity | 257 Kits |
| Distribution | Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY. |
| 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 |