Recall Z-1231-2017 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Quidel Corporation
Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests
| Date | Feb 22, 2017 (initiated Jan 25, 2017) |
| Status | Terminated |
| Reason | Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs. |
| Root cause | Mixed-up of materials/components |
| Action | Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate |
| Quantity | 1,010 packages |
| Distribution | Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX |
| 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 |