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Terminated

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

FDA Recall Z-0819-2013 · Posted 2013-02-14

Recalling FirmQuidel Corporation
Recall StatusTerminated
Product CodeGNX
Date Initiated2012-12-03
Date Terminated2014-01-31
Product Quantity13,090 kits (327,250 tests)

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.

Firm Action

Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112177SOFIA ANALYZER AND INFLUENZA A+B FIAQuidel Corp. · 2011-10-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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