FDA-Device2022-04-20Class II
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Luminex Corporation
Hazard
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Sold states
US: TX, CT, LA
Affected count
4 units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2022Don't want to check this manually?
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