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CHORUS INFLUENZA A IgG

DIESSE DIAGNOSTICA SENESE SPA · Model 81190 · UDI-DI 08033891327514

GNX

510(k) clearances

243

Adverse events (5 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2013-02-19	Remel Inc	Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
2012-12-03	Quidel Corporation	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.
2012-03-09	Princeton Biomeditech Corp	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
2012-03-09	Princeton Biomeditech Corp	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
2012-03-09	Princeton Biomeditech Corp	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
2008-07-02	Inverness Medical BioStar Inc.	Diagnostic kits for flu were distributed with incorrect components.
2007-03-28	Binax, Inc. dba IMPD	Tip of the foam swab could detach from the shaft causing injury to the patient.
2007-03-28	Binax, Inc. dba IMPD	Tip of the foam swab could detach from the shaft causing injury to the patient.
2007-03-28	Binax, Inc. dba IMPD	Tip of the foam swab could detach from the shaft causing injury to the patient.
2007-03-28	Binax, Inc. dba IMPD	Tip of the foam swab could detach from the shaft causing injury to the patient.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.