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 im
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is updating the carryover avoidance technical bulletin for its Lactate Dehydrogenase L-P test kit (Catalog Number LD3842) used on RX Instruments to introduce additional pipette washing steps. Without these additional steps, interference with the reagent could occur, potentially causing inconsistencies in quality control results, delays in processing patient samples, or incorrectly elevated test results.
The affected product was distributed nationwide in the United States, including West Virginia and Puerto Rico. The recalled lots are identified by GTIN 05055273204124 and lot numbers 480483, 495947, 523902, and 536342. The source does not specify a remedy 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: 21 Lot/code info: GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.