Changchun Wancheng Bio-Electron Co. recalled 500 Vivoo Protein Test strips on November 22, 2025. The devices may provide false diagnostic results, leading to inappropriate medical interventions. This recall affects consumers nationwide in Texas, Georgia, and California.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recalled product is the Vivoo Protein Test, model name Vivoo Protein Test/2024013122, with an expiration date of January 30, 2026. The tests were distributed nationwide in the United States, specifically in Texas, Georgia, and California.
The Vivoo Protein Test strips were marketed without proper FDA approval under the 510(k) process. They may yield false or inaccurate results when used by laypersons, which could lead to inappropriate medical actions.
No specific incidents of injury or death have been reported related to this recall. The potential for inaccurate results poses a high risk of inappropriate medical intervention.
Stop using the Vivoo Protein Test strips immediately. Follow the recall instructions provided by the manufacturer and contact Changchun Wancheng Bio-Electron Co. or your healthcare provider for guidance.
For more information, contact Changchun Wancheng Bio-Electron Co. at their official website or call customer service. Additional details can also be found on the FDA's recall page.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.