--- title: "Changchun Wancheng Bio-Electron Co., Ltd. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Changchun Wancheng Bio-Electron 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/changchun-wancheng-bio-electron-co-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Changchun Wancheng Bio-Electron Co., Ltd. recall records **11** reported ongoing 11 records in this archive. Latest source date Nov 22, 2025. 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 Nov 22, 2025 FDA device enforcement ### [LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalys...](https://isitonrecall.com/recall/fda-device-z-1257-2026-lotfancy-urinary-tract-infection-urine-uti-test-strips-palinoia-uti-10-parameter-reagent-strips-vaun/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIP...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1257-2026%22) Nov 22, 2025 FDA device enforcement ### [The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Pr...](https://isitonrecall.com/recall/fda-device-z-1258-2026-the-girlfriend-doctor-dr-anna-cabeca-keto-ph-uric-acid-test-strips-urimed-urinalysis-reagent-strips/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent St...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1258-2026%22) Nov 22, 2025 FDA device enforcement ### [LH One Step Ovulation Test Device (Urine)](https://isitonrecall.com/recall/fda-device-z-1259-2026-lh-one-step-ovulation-test-device-urine/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for LH One Step Ovulation Test Device (Urine)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1259-2026%22) Nov 22, 2025 FDA device enforcement ### [Menopause Test Cassette (Urine)](https://isitonrecall.com/recall/fda-device-z-1260-2026-menopause-test-cassette-urine/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Menopause Test Cassette (Urine)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1260-2026%22) Nov 22, 2025 FDA device enforcement ### [S. Typhi/Para Typhi A Antigen](https://isitonrecall.com/recall/fda-device-z-1261-2026-s-typhi-para-typhi-a-antigen/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for S. Typhi/Para Typhi A Antigen](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1261-2026%22) Nov 22, 2025 FDA device enforcement ### [Male Fertility Sperm Test for Home Use (Cassette)](https://isitonrecall.com/recall/fda-device-z-1262-2026-male-fertility-sperm-test-for-home-use-cassette/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Male Fertility Sperm Test for Home Use (Cassette)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1262-2026%22) Nov 22, 2025 FDA device enforcement ### [Exploro Highly Sensitive Male Fertility / Sperm Concentration Test](https://isitonrecall.com/recall/fda-device-z-1263-2026-exploro-highly-sensitive-male-fertility-sperm-concentration-test/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Exploro Highly Sensitive Male Fertility / Sperm Concentration Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1263-2026%22) Nov 22, 2025 FDA device enforcement ### [Vivoo pH Test](https://isitonrecall.com/recall/fda-device-z-1264-2026-vivoo-ph-test/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Vivoo pH Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1264-2026%22) Nov 22, 2025 FDA device enforcement ### [Vivoo Protein Test](https://isitonrecall.com/recall/fda-device-z-1265-2026-vivoo-protein-test/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Vivoo Protein Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1265-2026%22) Nov 22, 2025 FDA device enforcement ### [Vivoo Vaginal pH Test](https://isitonrecall.com/recall/fda-device-z-1266-2026-vivoo-vaginal-ph-test/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Vivoo Vaginal pH Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1266-2026%22) Nov 22, 2025 FDA device enforcement ### [Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test](https://isitonrecall.com/recall/fda-device-z-1267-2026-vivoo-sodium-test-vivoo-vitamin-c-test-vivoo-hydration-test/) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate m... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, GA, CA. [Official source for Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1267-2026%22) ## Reasons in these listed records - Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. These examples come from this result page and are not a ranking of every recall reason. ## Checking Changchun Wancheng Bio-Electron Co., Ltd. ### Is there a recall on changchun wancheng bio-electron co., ltd. right now? This archive contains 11 records, including 11 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 Changchun Wancheng Bio-Electron Co., Ltd.](https://isitonrecall.com/check/?q=Changchun%20Wancheng%20Bio-Electron%20Co.%2C%20Ltd.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)