FDA Medical Device Recalls (openFDA)
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 number
- Z-1401-2022
- Recalling firm
- North American Diagnostics
- 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
- Status
- Open, Classified
- Initiated
- 2022-06-15
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Lot: FLUSA 1020-1, Batches 8, 10, and 12
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3021477751
- Firm city
- Holly Hill
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28