North American Diagnostics

FDA Regulatory Profile

North American Diagnostics appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1401-2022, Class I) was initiated on June 15, 2022.

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