T2 Biosystems Inc

FDA Regulatory Profile

T2 Biosystems Inc appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2795-2016, Class II) was initiated on July 7, 2016.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2795-2016Class IIT2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartriJuly 7, 2016