Randox Laboratories Ltd.: 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.

Agency Publication Date: September 12, 2020

Affected Products

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.

GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342

Lot Numbers:

Numbers

Product: 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.

GTIN: 05055273204117; Lot Numbers: 511979

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86236

Status: Resolved

Manufacturer: Randox Laboratories Ltd.

Manufactured In: Ireland

Units Affected: 2 products (21; 4)

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Sources: FDA iRES · Raw API Response

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Affected Products

GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342

Lot Numbers:

Numbers

GTIN: 05055273204117; Lot Numbers: 511979

Lot Numbers:

Numbers