medical Class II Updated 2020-09-23

Randox Laboratories Ltd. recalls Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD384

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342
View official government recall

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