Facility

THERMO FISHER SCIENTIFIC OY

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

Key facts

5recalls · 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)	3007262384
Establishment type	Manufacture Medical Device
Location	2 RATASTIE VANTAA Uusimaa, FI 01620
Registration status	Active · expires 2026
Parent company	THERMO FISHER SCIENTIFIC INC. (owner-operator 2182773)
Brand names	Washing Solution 4.5%, Product No. IK703, IK704, 984030, 980929

Activity by year

Recalls (5)

Devices registered here (1)

Detergent
Product code JCB (opens in a new tab) · Class I · Pathology · 21 CFR 864.4010

Recalls & enforcement

Class IITerminated2021-02-01
Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual si…
Class IITerminated2020-04-29
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Class IITerminated2019-07-18
Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Class IITerminated2019-04-02
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Class IITerminated2012-11-29
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

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. “THERMO FISHER SCIENTIFIC OY (FEI 3007262384) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007262384-thermo-fisher-scientific-oy/

Not open yet

Alerts for THERMO FISHER SCIENTIFIC OY

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.