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Recall Observatory FDA recall evidence

Device product

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Z-0920-2022

April 22, 2019

Class II

Product summary

Firm
Luminex Corporation
Event
Event 89051
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0920-2022

Official wording

Reason: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

Code information: Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010

Distribution pattern: US: TX, CT, LA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.