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Recall Observatory FDA recall evidence

Device product

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

Z-0819-2013

December 03, 2012

Class II

Product summary

Firm
Quidel Corporation
Event
Event 64017
Status
Terminated
Classification
Class II
Quantity
13,090 kits (327,250 tests)
Official record key
device-enforcement:Z-0819-2013

Official wording

Reason: 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.

Code information: Lot # Range: 208228-214385, 707916-708108 (29 lots).

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.