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Recall Observatory FDA recall evidence

Device product

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05

Z-1865-2019

April 02, 2019

Class II

Product summary

Firm
Thermo Fisher Scientific (Asheville) LLC
Event
Event 82903
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1865-2019

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: 30024679S 300246796 300246797 300246798 300246799 300247393 300247394 30024739S 300247396 3002477S8

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