--- title: "Wondfo USA Co Ltd Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Wondfo USA Co Ltd recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/wondfo-usa-co-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Wondfo USA Co Ltd recall records **5** reported ongoing 5 records in this archive. Latest source date Apr 22, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 22, 2024 FDA device enforcement ### [Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10](https://isitonrecall.com/recall/fda-device-z-2030-2024-preview-strep-a-streptococcal-a-rapid-test-kits-part-numbers-a-pre-sta-25-b-pre-sta-a-10/) 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-consume... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2030-2024%22) Apr 22, 2024 FDA device enforcement ### [Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep ...](https://isitonrecall.com/recall/fda-device-z-2031-2024-clarity-and-clarity-diagnostics-llc-streptococcal-a-rapid-test-kits-labeled-as-a-clarity-strep-a-rap/) 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-consume... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Stre...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2031-2024%22) Apr 22, 2024 FDA device enforcement ### [Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARS...](https://isitonrecall.com/recall/fda-device-z-2032-2024-streptococcal-a-rapid-test-kits-labeled-as-easy-healthcare-corporation-areta-strep-a-swab-test-and-e/) 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-consume... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2032-2024%22) Apr 22, 2024 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-2033-2024-independent-medical-co-op-inc-streptococcal-a-rapid-test-kits-labeled-as-imco-strep-a-rapid-test-str/) 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-consume... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid T...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2033-2024%22) Apr 22, 2024 FDA device enforcement ### [Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Me...](https://isitonrecall.com/recall/fda-device-z-2034-2024-streptococcal-a-rapid-test-kits-labeled-as-wondfo-biotech-co-ltd-wondview-strep-a-test-kit-guangzhou/) 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-consume... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2034-2024%22) ## Reasons in these listed records - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Wondfo USA Co Ltd ### Is there a recall on wondfo usa co ltd right now? This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Wondfo USA Co Ltd](https://isitonrecall.com/check/?q=Wondfo%20USA%20Co%20Ltd) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)