Test, Sorbent, Fta-abs
Microbiology · 21 CFR 866.3830
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
- Integra Neuro SciencesTerminatedMar 15, 2005
LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Z-0622-05 · View FDA record ↗ - Integra Neuro SciencesTerminatedMar 15, 2005
LICOX temperature probe, Model C8.B
LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Z-0623-05 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.