Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
Publicado el 23 de septiembre de 2020 · Inicio del retiro: 11 de agosto de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Randox Laboratories Ltd.
- Distribuidor
- US Nationwide distribution including in the states of WV, and Puerto Rico.
- Lote
- GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Ireland
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