FDA Device Intelligence
HomeDevice types › LHJ

Staphylococcus Aureus Protein A Insoluble

FDA product code LHJ · Class 1 · Microbiology

2
Registered devices
0
Adverse events
2
Recalls
3
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2016-02-19Integrated Science Systems IncCustomer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
2006-08-17Becton Dickinson & Co.False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive C

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.