Lower riskMedical device recall · FDA · Published August 11, 2020
Randox Lactate Dehydrogenase P-L (UV) Device Recall: Potential Test Errors
Randox recalls Lactate Dehydrogenase P-L (UV) device (LD381: LD3818) for possible test errors due to reagent carryover. Affected units may cause delayed patient results or false high readings. Contact Randox for details.
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.
“Randox Lactate Dehydrogenase P-L (UV) Device Recall: Potential Test Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64502-randox-lactate-dehydrogenase-p-l-uv-device-recall-potential-test. Based on FDA recall #Z-2963-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2963-2020%22&limit=1).
The FDA announced on August 11, 2020, that Randox Laboratories Ltd. is recalling Lactate Dehydrogenase P-L, (UV), Catalog Number LD3818 due to potential erroneous elevated test results. The agency stated the recall addresses interference with the reagent that may lead to inconsistencies in Quality Control recovery.
How to tell if you have it
Brand: Randox
Product: Lactate Dehydrognease P-L, (UV), Catalog Number LD3818
UPC: 05055273204117
Lot Numbers: 511979
The hazard
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. The recall involves an update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a June 7, 2024, recall for missing FDA 510(k) for IVD Use and an April 5, 2024, recall for light leak risk in drug testing software. Other recent recalls of similar products include Copan Italia DTT Liquid Reagent Recall (October 29, 2025), Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026), and Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check for the product name 'Lactate Dehydrogenase P-L (UV)' with catalog number LD3818. Affected units were sold with lot number 511979 on RX daytona and RX imola instruments.
Brand
Randox
Product
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution including in the states of WV, and Puerto Rico.
Recall number
Product, codes & lots
Quantity
Z-2962-2020
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.; GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342
21
Z-2963-2020
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.; GTIN: 05055273204117; Lot Numbers: 511979
4
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the product name and catalog number on your device to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the states of WV, and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2963-2020 (August 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2963-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.