CLASS I ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report
Ltd And Sdi Labs Covid-19 Ag Rapid Test Device - Cat#: Co recalled
Jiangsu Well Biotech is recalling Ltd And Sdi Labs Covid-19 Ag Rapid Test Device - Cat#: Co-02, distributed in California. The recall was initiated on 9 Aug 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0001-2023
- FDA event ID
- 90773
- Recalling firm
- Jiangsu Well Biotech, Changzhou, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Aug 2022
- FDA classified
- 7 Oct 2022
- Reported
- 19 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Aug 2022 | Recall initiated by company | |
| 7 Oct 2022 | Classified by FDA | +59 days |
| 19 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Where it was distributed
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Questions about this recall
Why was it 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 lots are affected?
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Where was it sold?
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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