Sofia 20221R

• FDA 510(k) K112177 decided 24 Oct 2011 Active
• FDA GUDID UDI-DI 30014613802211 listed 7 Mar 2019 Listed

• • Terminated Z-0819-2013 FDA Class II ·initiated 3 Dec 2012 ·on shared 510(k) K112177

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 24 Oct 2011 Cleared FDA 510(k) K112177
2. 3 Dec 2012 Recall initiated FDA recalls Z-0819-2013
3. 7 Mar 2019 Listed FDA GUDID 30014613802211

Trade name

Sofia

Generic name

Fluorescent immunoassay analyser IVD, point-of-care

Model / Ref / Catalog

20221R

Primary DI / UDI-DI

30014613802211

510(k) Number

K112177 ↗

FDA product code

KHO

GMDN term

Fluorescent immunoassay analyser IVD, point-of-care

Device class

Class I

Regulation number

862.2560

GUDID distribution status

In Commercial Distribution

Category: Fluorescent immunoassay analyser IVD, point-of-care

Other devices filed under FDA product code KHO (FLUOROMETER, FOR CLINICAL USE).

• CLINISTAT TDA SERIES by Miles Laboratories, Inc.
• OPUS MAGNUM ANALYZER by Pb Diagnostic Systems, Inc.
• MICROFLUOR READER by Dynatech Corp.
• HEMAFLUOR REAGENT KIT by Helena Laboratories, Corp.
• VITROS 6801059 by Ortho-Clinical Diagnostics
• STRATUS IINTELLECT IMMUNOASSAY SYSTEM by Baxter Healthcare Corp
• OPUS IMMUNOASSAY SYSTEM by Pb Diagnostic Systems, Inc.
• SPECTROPHOTOMETER MODEL 3000 by The Perkin-Elmer Corp.
• SPECTROPHOTOMETER MODEL 650-40 by The Perkin-Elmer Corp.

• QuickVue 20125 Open recall

  Class I

  CE/IVDD FDA 510(k) K011097 Active Cleared 8 May 2001 +1authorizations

• Sofia 20253

  Class I

  FDA 510(k) K123793 Active Cleared 17 Jun 2013 GUDID on market

• MicroVue C1-Inhibitor

  Class II

  CE/IVDD GUDID on market

• Sofia 20298

  Class II

  GUDID on market

See all devices from Quidel Corp. →