Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Urgent Medical Device Correction notification letters dated 8/5/20 were issued to customers. Action to be taken: " Review your instrument testing order in line with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and enable additional pipette washes. " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and ensure all operators are aware of the recommendations. " Discuss the contents of th is notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns, please contact Randox Technical Services.