Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
FDA Recall #Z-0819-2013 — Class II — December 3, 2012
Product Description
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
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.
Recalling Firm
Quidel Corporation — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13,090 kits (327,250 tests)
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Code Information
Lot # Range: 208228-214385, 707916-708108 (29 lots).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated