Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance
Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure to address a technical issue (reagent carryover) that may lead to erroneous test results, with no reported injuries or illnesses.
Plain-English summary
Randox Laboratories Ltd. is recalling four units of Lactate Dehydrogenase P-L, (UV), Catalog Number LD3818, Lot Number 511979. This product is an in vitro diagnostic device intended for the quantitative determination of Lactate Dehydrogenase activity in serum and plasma, suitable for use on RX series instruments including the RX Daytona and RX Imola.
The recall is an update to a carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance. Interference to the Lactate Dehydrogenase reagent may be observed as inconsistencies in Quality Control recovery, which could lead to a delay in running patient samples or erroneous elevated test results.
The product was distributed nationwide in the US, including West Virginia and Puerto Rico. Users should stop using the affected reagent and contact Randox Laboratories for further instructions on implementing the additional pipette washes described in the technical bulletin.
The recalled product
- 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 dayt
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 05055273204117
- Lot Numbers: 511979
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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