Phase Scientific (Shenzhen) Company Limited
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (2)
- Visual, Pregnancy Hcg, Prescription UseProduct code JHI (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155
- Kit, Test, Pregnancy, Hcg, Over The CounterProduct code LCX (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155
Recalls & enforcement
- Class IIOngoing2023-10-25COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
Related
- All facilities operated by Phase Scientific International Limited
- PHASE SCIENTIFIC INTERNATIONAL LIMITED (HK)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Phase Scientific (Shenzhen) Company Limited (FEI 3027518847) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027518847-phase-scientific-shenzhen-company-limite/
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