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Thermo Fisher Scientific (Asheville) LLC

Last updated September 17, 2026

Information

Country: US
Address: 275 Aiken Rd, ASHEVILLE, NC, 28804
Website: www.thermofisher.com
This website did not respond in time when we last checked. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1036832
DUNS Number: —

Catalogue (71)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Thermo Scientific Forma	3110	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM17ML	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM34EL	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM48CA	FDA UDI	Class II	Active
Thermo Scientific ™	TDEC25286LD	FDA UDI	Class II	Active
CardinalHealth™	CARC06386LA	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM48ML	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM17TA	FDA UDI	Class II	Active
Isotemp™	IUEC25286LD	FDA UDI	Class II	Active
Vwr	VWRC06386LA	FDA UDI	Class II	Active
Isotemp™	IUEC06386LA	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM34MA	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM34MV	FDA UDI	Class II	Active
Isotemp™	IUEC39686LV	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM17MV	FDA UDI	Class II	Active
Thermo Scientific Forma	3131	FDA UDI	Class II	Active
Thermo Scientific Forma	311	FDA UDI	Class II	Active
BT Sure	AY759X3	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM34ML	FDA UDI	Class II	Active
Thermo Scientific ™ CryoMed™	TSCM48EL	FDA UDI	Class II	Active
Isotemp™	IUEC25286LA	FDA UDI	Class II	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 2, 2019	Z-1866-2019	—	terminated	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.
Apr 2, 2019	Z-1871-2019	—	terminated	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.
Apr 2, 2019	Z-1867-2019	—	terminated	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.
Apr 2, 2019	Z-1873-2019	—	terminated	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.
Apr 2, 2019	Z-1872-2019	—	terminated	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.
Apr 2, 2019	Z-1865-2019	—	terminated	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.
Apr 2, 2019	Z-1868-2019	—	terminated	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.
Apr 2, 2019	Z-1870-2019	—	terminated	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.
Apr 2, 2019	Z-1869-2019	—	terminated	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.
Nov 29, 2012	Z-1079-2013	—	terminated	Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.