Medical device recalls Moderate risk

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

Recall date
April 22, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0920-2022
FDA classification
Class II
Brand / firm
Luminex Corporation
Sold / distributed
US: TX, CT, LA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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