Facility

Phase Scientific (Shenzhen) Company Limited

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027518847
Establishment type	Repack or Relabel Medical Device
Location	Room 201, 301, No.3 3B, Hengtaiyu Bldg, Tangwei Community, Fenghuang Street, Guangming District Shenzhen Guangdong, CN 51810
Registration status	Active · expires 2026
Parent company	Phase Scientific International Limited (owner-operator 10083165)
Brand names	INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP

Activity by year

Recalls (1)

Devices registered here (2)

Visual, Pregnancy Hcg, Prescription Use
Product code JHI (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155
Kit, Test, Pregnancy, Hcg, Over The Counter
Product code LCX (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155

Recalls & enforcement

Class IIOngoing2023-10-25
COVID-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.

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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