Facility

ACTIM OY

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)	1000212994
Establishment type	Manufacture Medical Device
Location	Klovinpellontie 3 Espoo Uusimaa, FI 02180
Registration status	Active · expires 2026
Parent company	Actim Oy (owner-operator 10048029)
Brand names	Actim PROM Controls; Actim PROM

Activity by year

Recalls (1)

Devices registered here (1)

Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Product code OAM (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1550

Recalls & enforcement

Class IIOngoing2023-11-23
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

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. “ACTIM OY (FEI 1000212994) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000212994-actim-oy/

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