Recall Z-0819-2013— Quidel Corporation

Name: FDA recall Z-0819-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-03

Class II · Terminated

Class II FDA medical device recall by Quidel Corporation, initiated 2012-12-03, terminated 2014-01-31. It names one FDA 510(k) clearance: K112177. Product: Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.. 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..

Recalling firm: Quidel Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-12-03
Terminated: 2014-01-31
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K112177 — SOFIA ANALYZER AND INFLUENZA A+B FIAQuidel Corp.·cleared 2011-10-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.