Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Reported: February 20, 2013 Initiated: December 3, 2012 #Z-0819-2013
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.
Details
- Recalling Firm
- Quidel Corporation
- Units Affected
- 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
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.. Recalled by Quidel Corporation. Units affected: 13,090 kits (327,250 tests).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0819-2013.
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