Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Microbiology · 21 CFR 866.3330
Recent MDR events
243 adverse event reports on file
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 26, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00539
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 26, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00541
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 26, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00540
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 18, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00483
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 18, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00485
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 18, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00484
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 18, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00482
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 13, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00460
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 13, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00462
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KITAug 13, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00461
Event type breakdown
Recalls
10 recall events for this product code
- Remel IncTerminatedAug 13, 2013
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 swa
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Z-1962-2013 · View FDA record ↗ - Quidel CorporationTerminatedFeb 14, 2013
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.
Z-0819-2013 · View FDA record ↗ - Princeton Biomeditech CorpTerminatedAug 31, 2012
Orasure QuickFlu Rapid A+B Test
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Z-2306-2012 · View FDA record ↗ - Princeton Biomeditech CorpTerminatedAug 31, 2012
Poly stat Flu A & B Test
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Z-2307-2012 · View FDA record ↗ - Princeton Biomeditech CorpTerminatedAug 31, 2012
Status Flu A + B Test
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Z-2308-2012 · View FDA record ↗ - Inverness Medical BioStar Inc.TerminatedNov 3, 2008
BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Diagnostic kits for flu were distributed with incorrect components.
Z-0212-2009 · View FDA record ↗ - Binax, Inc. dba IMPDTerminatedMay 23, 2007
BinaxNOW Influenza A&B 10 Test KIT
Tip of the foam swab could detach from the shaft causing injury to the patient.
Z-0822-2007 · View FDA record ↗ - Binax, Inc. dba IMPDTerminatedMay 23, 2007
BinaxNOW Influenza A&B 22 Test Kit
Tip of the foam swab could detach from the shaft causing injury to the patient.
Z-0823-2007 · View FDA record ↗ - Binax, Inc. dba IMPDTerminatedMay 23, 2007
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.
Z-0825-2007 · View FDA record ↗ - Binax, Inc. dba IMPDTerminatedMay 23, 2007
BinaxNOW A&B Kit 10 Test Kit (Japan)
Tip of the foam swab could detach from the shaft causing injury to the patient.
Z-0826-2007 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Laboratorios Scantibodies S.a. De C.v.
TECATE Baja California, MX
Scantibodies Laboratory Inc.
San Diego, CA, US
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Zapalign Llc
Fort Lauderdale, FL, US
Intelimas Corporation
Londonderry, NH, US
Sts Corporation
Duluth, GA, US
Diesse Diagnostica Senese S.p.a
MONTERIGGIONI Siena, IT
Remel Europe Ltd
DARTFORD, KENT, GB
Laboratorios Scantibodies, S.a. De C.v.
Tijuana Baja California, MX
510(k) clearances
18 clearances for this product code
- Alere Scarborough, Inc D/B/A Binax, Inc.Dec 5, 2013
K133411 · ALERE BINAXNOW INFLUENZA A & B CARD
- Sa Scientific , Ltd.Aug 22, 2013
K132352 · SAS FLUALERT A & B, SAS INFLUENZA A TEST
- Remel, Inc.Jul 12, 2013
K131804 · REMEL XPECT FLU A&B
- Quidel CorporationJul 5, 2013
K131599 · QUICK VUE INFLUENZA
- Quidel Corp.Jul 5, 2013
K131606 · SOFIA INFLUENZA A+B FIA
- Quidel Corp.Jun 28, 2013
K131619 · QUICKVUE INFLUENZA A+B
- SEKISUI Diagnostics, LLCNov 5, 2012
K123182 · OSOM INFLUENZA A&B TEST MODEL 190
- Zymetx, Inc.Sep 10, 1997
K971494 · VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES