FDAFDA · Food and drugs·Recall number Z-0819-2013
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Published February 20, 2013 · Recall initiated: December 3, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quidel Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
- Lot
- Lot # Range: 208228-214385, 707916-708108 (29 lots).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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