Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Str
Summary
The FDA issued a Class II for Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IM by Wondfo USA Co Ltd. Reason: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and .
Details
Source
Device Recall
External ID
Z-2033-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
Lot/Code Info: Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007
Quantity Affected: 102,500 units
Reason for Recall
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-22
Company
Willowbrook, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wondfo USA Co Ltd has 7 FDA actions in our database, including 5 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Wondfo USA 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 Wondfo USA Co Ltd have FDA actions?
Wondfo USA Co Ltd has 7 FDA actions in our database, including 5 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2033-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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