Summary
The FDA issued a Class I for Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test by Woodside Acquisitions Inc.. Reason: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States..
Details
Source
Device Recall
External ID
Z-1044-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Lot/Code Info: All lots
Quantity Affected: 34,240 units
Reason for Recall
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Distribution
US distributions to states of: AL and GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-09
Company
tyrone, PA
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 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Woodside Acquisitions Inc. has 2 FDA actions in our database, including 2 recalls.
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 (Woodside Acquisitions Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Woodside Acquisitions Inc. have FDA actions?
Woodside Acquisitions Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1044-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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