Device recall: LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical…
Class II FDA enforcement event 97801. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Changchun Wancheng Bio-Electron Co., Ltd. started this device recall on 22 Nov 2025. The firm address in the FDA record is in Changchun. FDA put the recall in Class II. FDA event 97801 has 11 product records. The first FDA enforcement report date is 11 Feb 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of TX, GA, CA.
Recalling firm
Changchun Wancheng Bio-Electron Co., Ltd., Changchun, N/A, China.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1257-2026 | 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 Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI) | 91,366 | Class II | Ongoing | 11 Feb 2026 |
| Z-1258-2026 | 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, Protein; Vivoo Ketone Test | 32,500 | Class II | Ongoing | 11 Feb 2026 |
| Z-1259-2026 | LH One Step Ovulation Test Device (Urine) | 1,000 | Class II | Ongoing | 11 Feb 2026 |
| Z-1260-2026 | Menopause Test Cassette (Urine) | 1,000 | Class II | Ongoing | 11 Feb 2026 |
| Z-1261-2026 | S. Typhi/Para Typhi A Antigen | 1,000 | Class II | Ongoing | 11 Feb 2026 |
| Z-1262-2026 | Male Fertility Sperm Test for Home Use (Cassette) | 1,000 | Class II | Ongoing | 11 Feb 2026 |
| Z-1263-2026 | Exploro Highly Sensitive Male Fertility / Sperm Concentration Test | 4,800 | Class II | Ongoing | 11 Feb 2026 |
| Z-1264-2026 | Vivoo pH Test | 500 | Class II | Ongoing | 11 Feb 2026 |
| Z-1265-2026 | Vivoo Protein Test | 500 | Class II | Ongoing | 11 Feb 2026 |
| Z-1266-2026 | Vivoo Vaginal pH Test | 3,000 | Class II | Ongoing | 11 Feb 2026 |
| Z-1267-2026 | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test | 3,300 | Class II | Ongoing | 11 Feb 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 11
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1257-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 97801. https://recallregister.com/fda/ii/97801/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of TX, GA, CA.
- What quantity of product is in FDA event 97801?
- The event has 11 product records. The first record gives this quantity:
91,366
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.