Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
This recall has been terminated (originally issued February 14, 2013).
- Company
- Quidel Corporation
- Recall Initiated
- December 3, 2012
- Posted
- February 14, 2013
- Terminated
- January 31, 2014
- Recall Number
- Z-0819-2013
- Quantity
- 13,090 kits (327,250 tests)
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Lot / Code Info
Lot # Range: 208228-214385, 707916-708108 (29 lots).
Root Cause
Nonconforming Material/Component
Action Taken
Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.