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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