Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps
Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and 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 classified as FDA Class II and involves a procedural update to prevent erroneous test results and delays, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Randox Laboratories Ltd. is recalling 21 units of Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842. This product is intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma and is suitable for use on RX series instruments, including the RX Daytona and RX Imola. The affected lot numbers are 480483, 495947, 523902, and 536342, with GTIN 05055273204124.
The recall is an update to a carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance. The source text notes that interference to the Lactate Dehydrogenase reagent would be observed as inconsistencies in Quality Control recovery. This may lead to a delay in running patient samples or erroneous elevated test results. Additional pipette washes can be implemented as described in the technical bulletin.
The product was distributed nationwide in the US, including in the states of West Virginia and Puerto Rico. Users should refer to the updated technical bulletin for the additional pipette wash steps to avoid reagent carryover.
The recalled product
- 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
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 21
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: 05055273204124
- Lot Numbers: 480483 495947 523902 536342
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03