RegWardenFDA facility compliance records
Facility

PHASE SCIENTIFIC INTERNATIONAL LIMITED

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

Activity by year

FDA actions on record by year2023: 1 recalls20172018201920202021202212023202420252026
  • 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.

Related

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 INTERNATIONAL LIMITED (FEI 3017887566) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017887566-phase-scientific-international-limited/

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