Facility

THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

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

Key facts

5recalls · worst Class II

2inspections · worst VAI

—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)	1523845
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	401 MILLCREEK RD. MARIETTA, OH, US 45750
Registration status	Active · expires 2026
Parent company	THERMO FISHER SCIENTIFIC INC. (owner-operator 2182773)
Brand names	TSX Series Blood Bank Refrigerator TSX2-2204BA; Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX70086MA; TSX Series Blood Bank Refrigerator TSX2-5004BA; Thermo Scientific HERAfreeze Ultra Low Temperature Freezer HDE60086MA, HDE60086MD, HDE60086MV; Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV; Thermo Scientific Forma Blood Bank Refrigerator FRBB5004A, FRBB5004D, FRBB5004V, FRBB5004W; HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE50040LA, HDE50040LD,HDE50040LV; Thermo Scientific CryoMed TSCM48EV (CryoMed MD 48L w/ print 230v); Ultra-Low Temperature Freezer TDEC39686LV; Thermo Scientific Jewett Blood Bank Refrigerator JBB404A, JBB404D, JBB404V, JBB404W; Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A, JBB1204D, JBB1204V, JBB1204W; HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE60040LA, HDE60040LD,HDE60040LV

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Refrigerator, Freezer, Blood Storage
Product code KSE (opens in a new tab) · Class II · Hematology · 21 CFR 864.9700

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.

FDA inspections (2)

VAI2025-08-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-08-23
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.

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 (ASHEVILLE) LLC (FEI 1523845) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1523845-thermo-fisher-scientific-asheville-llc/

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