Z-0819-2013 Class II Terminated
FDA device recall Z-0819-2013 was initiated by Quidel Corporation on December 3, 2012 and is designated Class II. 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. The recall status is terminated (terminated January 31, 2014). Affected quantity: 13,090 kits (327,250 tests).
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- December 3, 2012
- Termination Date
- January 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,090 kits (327,250 tests)
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.
Distribution Pattern
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).