Staphylococcus Aureus Protein A Insoluble
Microbiology · 21 CFR 866.3700
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
2 recall events for this product code
- Integrated Science Systems IncTerminatedJun 3, 2016
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Z-1911-2016 · View FDA record ↗ - Becton Dickinson & Co.TerminatedSep 16, 2006
BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents
False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.
Z-1505-06 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
3 clearances for this product code