Recall Z-2962-2020 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Randox Laboratories Ltd.
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.
| Date | Aug 11, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. Tr |
| Quantity | 21 |
| Distribution | US Nationwide distribution including in the states of WV, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970684 | LACTATE DEHYDROGENASE (LD) Randox Laboratories, Ltd., May 7, 1997 |