Z-1401-2022Class I

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen...

Name: Z-1401-2022 SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen...
Creator: North American Diagnostics
Published: 2022-06-15
License: https://open.fda.gov/license/

North American Diagnostics / initiated 2022-06-15 / Open, Classified

FDA source

North American Diagnostics began a recall of 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... on 2022-06-15. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1401-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-06-15
Posted: 2022-07-29
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
Product code: QKP Coronavirus Antigen Detection Test System.
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.
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 [email protected]. " 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, [email protected], 407-312-7104.
Quantity in commerce: 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.
Product codes and lots: Lot: FLUSA 1020-1, Batches 8, 10, and 12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1401-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1401-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-07-29

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)