Mechatronics USA

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1695-2023Class IIIRR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control mApril 14, 2023
Z-1694-2023Class IIIRR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality cApril 14, 2023