Medical device recalls Moderate risk

Luminex Corporation recalls VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucle…

Recall date
December 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0054-2021
FDA classification
Class II
Brand / firm
Luminex Corporation
Sold / distributed
US distribution in MO. No OUS

Why it was recalled

No results/incorrect results due to failure of the hybridization heater.

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 No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

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