Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
FDA adverse event reports and recall history for antigens, cf (including cf control), influenza virus a, b, c (product code GNX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 243
- Deaths
- 5
- Injuries
- 28
- Malfunctions
- 209
Reports per year
Source: FDA adverse event reports by year received, 1995–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-08-13TerminatedEmployee error
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
- 2013-02-14TerminatedNonconforming Material/Component
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
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.
- 2012-08-31TerminatedNonconforming Material/Component
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- 2012-08-31TerminatedNonconforming Material/Component
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- 2012-08-31TerminatedNonconforming Material/Component
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- 2008-11-03TerminatedMixed-up of materials/components
BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Diagnostic kits for flu were distributed with incorrect components.
- 2007-05-23TerminatedOther
BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
Tip of the foam swab could detach from the shaft causing injury to the patient.
- 2007-05-23TerminatedOther
BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper
Tip of the foam swab could detach from the shaft causing injury to the patient.
- 2007-05-23TerminatedOther
BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper
Tip of the foam swab could detach from the shaft causing injury to the patient.
- 2007-05-23TerminatedOther
BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper
Tip of the foam swab could detach from the shaft causing injury to the patient.
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