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Trinity Biotech
MARDX DIAGNOSTICS, INC. · Model 31-8203 · UDI-DI 05391516747745
0
510(k) clearances
0
Adverse events
2
Recalls
0
Facilities
Description
FTA-ABS Sorbent, 5.0 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-01-21 | Integra Neuro Sciences | 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. Elev |
| 2005-01-21 | Integra Neuro Sciences | 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. Elev |
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