Recall Z-1401-2022 ยท QKP Coronavirus Antigen Detection Test System.
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
| Date | Jun 15, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | No Marketing Application |
| Action | 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 cus |
| Quantity | 122,366 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.