RegWardenFDA facility compliance records
Facility

Ascensia Diabetes Care Poland Sp. z o.o.

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 (1)

  • Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
    Product code JIL (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1340

Recalls & enforcement

  • Class IIOngoing2023-05-19
    Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit o…

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. “Ascensia Diabetes Care Poland Sp. z o.o. (FEI 3038419886) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3038419886-ascensia-diabetes-care-poland-sp-z-o-o/

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