Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 5, 2022
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determi…
Migo Trading LLC recalled FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test - a moderate-severity action.
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test was recalled by Migo Trading LLC in January 5, 2022. Reason: Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product ha…. Check the official notice for the remedy. Verify recall #Z-0421-2022 with the FDA Devices before acting.
The recall
Migo Trading LLC issued this moderate-severity FDA Devices recall-Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product ha….
- Moderate
- severity level
- 200K units
- affected scope
- Class II
- classification
- January 5, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0421-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0421-2022) was formally reported on January 5, 2022, with the manufacturer initiating the action on November 4, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Migo Trading LLC is listed as the recalling firm, operating out of Dayton, NV. Federal records list the affected scope as 200,100 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the s… Distribution data in the federal record shows the product reached: NY. 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
200,100 units
Related Recalls
6
6 from same agency
Product description
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Reason for recall
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0421-2022 |
| Date reported | January 5, 2022 |
| Date initiated | November 4, 2021 |
| Recalling firm | Migo Trading LLC |
| Firm location | Dayton, NV |
| Affected scope | 200,100 units |
| Distribution | NY |
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-0421-2022) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test. Recalled by Migo Trading LLC. Units affected: 200,100 units.
Why was this product recalled? ▼
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 5, 2022. Severity: Moderate. Recall number: Z-0421-2022.
Where was the recalled product distributed? ▼
Distribution: NY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0421-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 5, 2022. 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 August 2026.