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. Source coverage and dates.

Records and reported status

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...

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 IIReported 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...
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...

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 IIReported 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...
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Menopause Test Cassette (Urine)
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for S. Typhi/Para Typhi A Antigen
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Male Fertility Sperm Test for Home Use (Cassette)
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Vivoo pH Test
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Vivoo Protein Test
FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TX, GA, CA.

Official source for Vivoo Vaginal pH Test
FDA device enforcement

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 IIReported 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

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 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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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