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