Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - 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.
Published September 23, 2020 · Recall initiated: August 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide distribution including in the states of WV, and Puerto Rico.
- Lot
- GTIN: 05055273204117; Lot Numbers: 511979
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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