Vivoo sodium and hydration tests recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states the devices may give false or inaccurate results leading to inappropriate medical intervention, and no injuries are reported.
Plain-English summary
Vivoo Sodium Test, Vivoo Vitamin C Test and Vivoo Hydration Test is being recalled by Changchun Wancheng Bio-Electron Co., Ltd.
The record states that 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, and that the devices may cause a false or inaccurate diagnostic result by a lay person and lead to inappropriate medical intervention.
The record lists 3,300 units, with product names, lot numbers and expiration dates recorded in the enforcement record. The record gives distribution as US nationwide in the states of Texas, Georgia and California. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Consumers should follow the seller's return instructions and speak to a clinician rather than relying on a result from an affected test.
The recalled product
- Product
- Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Medical Device — Test strip
- Hazard
- premarket-clearance
- false-results
- near-patient-testing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026)
- Vivoo Vitamin C Test/2024013124(01/30/2026)
- Vivoo Hydration Test/2024013119(01/30/2026)
- 2025051519(05/14/2027)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22