Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Summary
The FDA issued a Class II for Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolyti by Altruan GmbH. Reason: Product not cleared by the FDA..
Details
Source
Device Recall
External ID
Z-1559-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Lot/Code Info: Model No. 41972; No UDI; Lot Code: 6933289812337.
Quantity Affected: 188 units
Reason for Recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Massing, N/A
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 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Altruan GmbH has 3 FDA actions in our database, including 3 recalls.
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 (Altruan GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Altruan GmbH have FDA actions?
Altruan GmbH has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1559-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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