Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Microbiology · 21 CFR 866.3550
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
5 recall events for this product code
- Becton Dickinson & Co.TerminatedJul 15, 2010
Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
Z-2025-2010 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella O Group D Antigen (9-12) (Typhoid O)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0312-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella Flagellar d Antigen (Typhoid H)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0315-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella O Group A Antigen (1-2-12)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0316-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella O Group B Antigen (1-4-5-12)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0317-05 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
60 clearances for this product code
- Lee Laboratories, Inc.Aug 25, 1997
K972388 · VISTA ANTIGEN SALMONELLA O GROUP C
- Lee Laboratories, Inc.Aug 25, 1997
K972387 · VISTA ANTIGEN SALMONELLA O GROUP A
- Lee Laboratories, Inc.Aug 25, 1997
K972391 · VISTA ANTIGEN SALMONELLA H B
- Lee Laboratories, Inc.Aug 25, 1997
K972389 · VISTA ANTIGEN SALMONELLA H D
- Lee Laboratories, Inc.Aug 25, 1997
K972392 · VISTA ANTIGEN SALMONELLA H A
- Lee Laboratories, Inc.Aug 25, 1997
K972390 · VISTA ANTIGEN SALMONELLA H C
- Lee Laboratories, Inc.Aug 25, 1997
K972386 · VISTA ANTIGEN SALMONELLA O GROUP B
- Lee Laboratories, Inc.Aug 25, 1997
K972395 · VISTA ANTIGEN SALMONELLA O GROUP D