Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Microbiology · 21 CFR 866.3480
Recent MDR events
28 adverse event reports on file
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV CLIA-WAIVED KITMar 5, 2026MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2026-00186
- CONSULT RSV ANTIGEN TESTFeb 9, 2026MalfunctionHealgen Scientific Llc3009238284-2026-00003
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KITJun 26, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00238
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KITJun 26, 2025MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2025-00239
- BINAXNOW RSV WAIVED 22TMar 21, 2024MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2024-00292
- BINAXNOW RSV WAIVED 22TJan 31, 2024InjuryAbbott Diagnostics Scarborough, Inc.1221359-2024-00124
- KIT RSV 30 TEST PHYSICIAN VERITORDec 1, 2023MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2023-00122
- BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KITOct 16, 2023MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3006948883-2023-00108
- KIT RSV 30 TEST PHYSICIAN VERITORAug 11, 2023MalfunctionBd Rapis Diagnostics (suzhou) Co. Ltd.3014704491-2023-00444
- BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEMMay 2, 2023MalfunctionBecton, Dickinson & Co. (sparks)3007420875-2023-00046
Event type breakdown
Recalls
3 recall events for this product code
- Binax, Inc. dba IMPDTerminatedMay 23, 2007
BinaxNOW RSV 10 Test Kit
Tip of the foam swab could detach from the shaft causing injury to the patient.
Z-0824-2007 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJul 20, 2004
Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
Diagnostic test kit may exhibit false positive results.
Z-0373-04 · View FDA record ↗ - Binax, Inc.TerminatedJul 20, 2004
NOW RSV Test
Pouch integrity compromised
Z-0778-04 · View FDA record ↗
Registered firms
59 firms currently registered for this product code
Healgen Scientific Llc
Houston, TX, US
Btnx Inc.
Pickering Ontario, CA
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Laboratorios Scantibodies S.a. De C.v.
TECATE Baja California, MX
Minlong Pharmaceutical Biotechnology (shenzhen) Co., Ltd.
shenzhen Guangdong, CN
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
Becton, Dickinson & Co.
SPARKS, MD, US
Panion & Bf Biotech Inc. Xizhi Second Factory
New Taipei City, TW
Laboratorios Scantibodies, S.a. De C.v.
Tijuana Baja California, MX
Via Systems Manufacturas
Tijuana Baja California, MX
Quidel Corp.
SAN DIEGO, CA, US
Ortho-clinical Diagnostics, Inc.
Carlsbad, CA, US
Hangzhou Clongene Biotech Co., Ltd.
Hangzhou Zhejiang, CN
Cbr Enterprise Limited
Hong Kong, HK
Biosquare Inc.
Hwaseong-si Gyeonggi, KR
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Planet Innovation Products, Inc.
IRVINE, CA, US
Sts Corporation
Duluth, GA, US
510(k) clearances
32 clearances for this product code
- Hangzhou Clongene Biotech Co., Ltd.Jan 30, 2026
K253318 · Clungene RSV Antigen Rapid Test
- Nano-Ditech CorporationJul 30, 2024
K240280 · Nano-Check RSV Test
- Quidel CorporationFeb 22, 2017
K162911 · Sofia RSV FIA on Sofia 2 analyzer
- Becton, Dickinson & CONov 15, 2013
K133140 · BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
- Becton, Dickinson and CompanyNov 7, 2013
K132456 · BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
- Quidel Corp.Aug 13, 2013
K130398 · SOFIA(R) RSV FIA
- Becton, Dickinson and CompanySep 18, 2012
K121633 · BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
- Quidel Corp.Sep 24, 2010
K101918 · QUICKVUE RSV 10