Recall Z-1401-2022— North American Diagnostics
Class I · Ongoing
Class I FDA medical device recall by North American Diagnostics, initiated 2022-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT. Reason: Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA..
- Recalling firm
- North American Diagnostics
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-06-15
- Firm location
- Holly Hill, FL, United States
Product description
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Reason for recall
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.