RegWardenFDA facility compliance records
Facility

Tech Group Europe Limited t/a West

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

Activity by year

FDA actions on record by year2019: 1 inspections; 2023: 1 inspections; 2024: 1 recalls2017201812019202020212022120231202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
    Product code PZE (opens in a new tab) · Class III · Unknown

Recalls & enforcement

  • Class IIOngoing2024-09-24
    Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

FDA inspections (2)

  • VAI2023-04-27
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2019-10-23
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “Tech Group Europe Limited t/a West (FEI 3010893867) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010893867-tech-group-europe-limited-t-a-west/

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