Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Summary
The FDA issued a Class I for Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: by Jiangsu Well Biotech Co.,Ltd.. Reason: Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance..
Details
Source
Device Recall
External ID
Z-0001-2023
Action Date
2022-10-19
Status
Ongoing
Category
device
Product Description
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Lot/Code Info: Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Quantity Affected: 620,000 tests
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.
Distribution
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-09
Company
Changzhou, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jiangsu Well Biotech Co.,Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jiangsu Well Biotech Co.,Ltd. have FDA actions?
This is the only FDA action we have on record for Jiangsu Well Biotech Co.,Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0001-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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