Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported October 19, 2022
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Jiangsu Well Biotech Co.,Ltd. recalled Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 - a critical-severity action.
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 was recalled by Jiangsu Well Biotech Co.,Ltd. in October 19, 2022. Reason: Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Mark…. Check the official notice for the remedy. Verify recall #Z-0001-2023 with the FDA Devices before acting.
The recall
Jiangsu Well Biotech Co.,Ltd. issued this critical-severity FDA Devices recall-Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Mark….
- Critical
- severity level
- Class I
- classification
- October 19, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0001-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0001-2023) was formally reported on October 19, 2022, with the manufacturer initiating the action on August 9, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Jiangsu Well Biotech Co.,Ltd. is listed as the recalling firm, operating out of Changzhou, N/A. Federal records list the affected scope as 620,000 tests.
The documented reason for this recall is: Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance. Distribution data in the federal record shows the product reached: U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A. 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 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
620,000 tests
Related Recalls
6
6 from same agency
Product description
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Reason for recall
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0001-2023 |
| Date reported | October 19, 2022 |
| Date initiated | August 9, 2022 |
| Recalling firm | Jiangsu Well Biotech Co.,Ltd. |
| Firm location | Changzhou, N/A |
| Affected scope | 620,000 tests |
| Distribution | U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A |
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-0001-2023) 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? ▼
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02. Recalled by Jiangsu Well Biotech Co.,Ltd.. Units affected: 620,000 tests.
Why was this product recalled? ▼
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2022. Severity: Critical. Recall number: Z-0001-2023.
Where was the recalled product distributed? ▼
Distribution: U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0001-2023) 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.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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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 October 19, 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.