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.
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is updating instructions for its Lactate Dehydrogenase P-L reagent (Catalog Number LD3818), used to measure lactate dehydrogenase activity in blood samples on RX Instruments. The issue involves potential reagent carryover during testing, which could cause inconsistent quality control results or delayed patient sample testing. In some cases, erroneous elevated test results may occur.
Four units of this product with lot number 511979 were distributed nationwide in the United States, including in West Virginia and Puerto Rico. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution including in the states of WV, and Puerto Rico. Quantity: 4 Lot/code info: GTIN: 05055273204117; Lot Numbers: 511979
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.