Randox Laboratories Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2962-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 11, 2020

Date Posted: September 23, 2020

Recall Number: Z-2962-2020

Event ID: 86236

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.

Status: Terminated

Product Quantity: 21

Code Information:

GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342

Distribution Pattern:

US Nationwide distribution including in the states of WV, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated