North American Diagnostics 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
North American Diagnostics
Lot Codes / Batch Numbers
Lot: FLUSA 1020-1, Batches 8, 10, and 12
Products Sold
Lot: FLUSA 1020-1, Batches 8, 10, and 12
North American Diagnostics is recalling SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid due to Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing appro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated their recall by email on 06/15/2022. The letter explained the issue and requested the consignee take the following actions: "" Immediately destroy all unused product to North American Diagnostics Inc. " Immediately identify all affected product in your inventory and segregate to avoid inadvertent use or further distribution. " Complete the attached response form and return it to Elizabeth Lashinsky ealash52@gmail.com. " If you have further distributed any of these products, please notify your customers immediately with a copy of this notice, and please request that your customers destroy any product they may have in inventory and confirm in writing that they have done so. " If you have relabeled the product prior to distributing it, please indicate the number below and the name on the label. If you have questions or concerns regarding this recall, or problems with the product, please contact Elizabeth A. Lashinsky, Manager, ealash52@gmail.com, 407-312-7104.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026