Quidel Corporation recalls Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

Recalled February 20, 2013 · FDA recall Z-0819-2013 · Quidel

Hazard

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. · FDA Class II

Units

13,090 kits (327,250 tests)

Sold at

Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK

Description

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.

Product

Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

Manufacturer(s)

Quidel Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →