Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported August 10, 2022
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
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 authorizat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
North American Diagnostics recalled SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test,… - a critical-severity action.
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test,… was recalled by North American Diagnostics in August 10, 2022. Reason: Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in …. Check the official notice for the remedy. Verify recall #Z-1401-2022 with the FDA Devices before acting.
The recall
North American Diagnostics issued this critical-severity FDA Devices recall — Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in ….
- Critical
- severity level
- 122K units
- affected scope
- Class I
- classification
- August 10, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1401-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1401-2022) was formally reported on August 10, 2022, with the manufacturer initiating the action on June 15, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. North American Diagnostics is listed as the recalling firm, operating out of Holly Hill, FL. Federal records list the affected scope as 122,366 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
122,366 units
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1401-2022 |
| Date reported | August 10, 2022 |
| Date initiated | June 15, 2022 |
| Recalling firm | North American Diagnostics |
| Firm location | Holly Hill, FL |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1401-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by North American Diagnostics. Units affected: 122,366 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2022. Severity: Critical. Recall number: Z-1401-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1401-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Continue exploring
Keep tracking product safety across the federal recall archive.
Recall Checker
Search the full archive by product name, brand, or recall number across every agency.
Check a product →
FDA Devices recalls
Every recall issued by FDA Devices, newest first.
Browse the feed →
RecallRadar
Live feed of the latest recalls across the FDA, CPSC and NHTSA — filter by agency and severity.
View the live feed →
Rankings
The largest recalls by units affected and the most-recalled product categories.
See the rankings →
Browse by category
Find recalls by product type to spot recurring defect patterns.
All categories →
What to do next
A step-by-step guide to refunds, repairs, and returns after a recall.
Read the guide →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Med…
Medline Industries, LP · 2026-06-03
FDA Devices Critical
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella C…
Abiomed, Inc. · 2026-06-03
FDA Devices Moderate
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCA…
GE Medical Systems Information Technologies Inc · 2026-06-03
Compare this recall with GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L… →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported August 10, 2022.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.