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Recall Observatory FDA recall evidence

Device product

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10

Z-1866-2019

April 02, 2019

Class II

Product summary

Firm
Thermo Fisher Scientific (Asheville) LLC
Event
Event 82903
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1866-2019

Official wording

Reason: 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.

Code information: Serial Numbers: 300247769 300247772 300247773 300247774 30024777S

Distribution pattern: CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error