PlainRecordsWondfo Streptococcal A At-Home Self-Test… and 2 more products
- Reason
- Product not cleared by the FDA.
- Status
- Ongoing
- Distribution
- US Nationwide distribution.
- Enforcement report date
- March 18, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Altruan GmbH
- Reason
- Product not cleared by the FDA.
- Distribution pattern
- US Nationwide distribution.
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Product not cleared by the FDA.”Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection., FDA enforcement report, 2026-03-18. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Antigens, All Groups, Streptococcus Spp.
3 products in this recall
Wondfo Streptococcal A At-Home Self-Test…
- Product
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- Quantity
- 188 units
- Codes and lots
- Model No. 41972; No UDI; Lot Code: 6933289812337.
- Recall started
- Dec. 19, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Antigens, All Groups, Streptococcus Spp.
- Root cause (FDA)
- No Marketing Application
- What the company told customers
- The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.
- Recall number
- Z-1559-2026
Clearest Strep-A Cassette Test…
- Product
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
- Quantity
- 188 units
- Codes and lots
- Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
- Recall started
- Dec. 19, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Antigens, All Groups, Streptococcus Spp.
- Root cause (FDA)
- No Marketing Application
- What the company told customers
- The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.
- Recall number
- Z-1560-2026
Brand Name: Bisaf Strep A Self-Test…
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Quantity
- 188 units
- Codes and lots
- Model No. AL-42153; No UDI; Lot Code: 6952804827274.
- Recall started
- Dec. 19, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Antigens, All Groups, Streptococcus Spp.
- Root cause (FDA)
- No Marketing Application
- What the company told customers
- The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.
- Recall number
- Z-1561-2026
This recall among the others
- FDA's enforcement report came 89 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1559-2026, Z-1560-2026, Z-1561-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1559-2026, March 18, 2026. "Wondfo Streptococcal A At-Home Self-Test… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-1559-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections