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Fisherbrand

FISHER SCIENTIFIC COMPANY L.L.C. · Model FB3532DH · UDI-DI 00613647024409

JTQ
10
510(k) clearances
28
Adverse events
11
Recalls
54
Facilities

Description

ISOTEMP DH CO2 TC 120V

Recalls

DateFirmReason
2026-02-06BD KIESTRA LAB AUTOMATIONIn certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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
2019-04-02Thermo Fisher Scientific (Asheville) LLCProduct 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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.