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 is recalling a specific lab test device that could cause delayed patient results or false high test readings if reagent carryover occurs. This is a technical issue with the device's use on certain lab instruments.
The device may have reagent carryover issues when used on RX instruments, causing inconsistent test results. This could lead to delayed patient testing or false elevated test results if not properly addressed with additional pipette washes.
Lab technicians and healthcare facilities using the Randox Lactate Dehydrogenase P-L (UV) device (LD3818) on RX series instruments. Those most at risk are labs handling patient samples with this device.
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.
Verify the product name and catalog number on your device to confirm if it's affected.
The device may have reagent carryover issues when used on RX instruments, causing inconsistent test results that could delay patient testing or produce false elevated test results.
Check for the product name 'Lactate Dehydrogenase P-L (UV)' with catalog number LD3818 and lot number 511979 on RX daytona or RX imola instruments.
The recall does not require immediate action; check device details to confirm if affected. If affected, follow the technical bulletin for additional pipette washes to avoid reagent carryover.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2963-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2963-2020 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
