North American Diagnostics

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1401-2022Class ISARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral RapidJune 15, 2022