Randox recalls LDH test devices (catalog LD3842) due to potential inaccurate patient results from reagent carryover. Affected units may cause delayed testing 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 Lactate Dehydrogenase (LDH) test devices that could cause inaccurate patient test results. If the device is not properly cleaned between tests, it might lead to delayed patient testing or false elevated results.
The device may show inconsistent results if not cleaned properly between tests. This can cause delays in patient testing or false elevated test results, potentially affecting diagnosis.
Lab technicians and healthcare facilities using Randox LDH test devices (catalog LD3842) on RX series instruments. Those handling the devices without proper cleaning steps are most at risk.
Check for the catalog number LD3842 on the device. Affected units were sold with lot numbers 480483, 495947, 523902, or 536342.
Ensure proper cleaning between tests using the technical bulletin steps to avoid reagent carryover.
The device may cause inaccurate test results if not cleaned properly between tests, leading to delayed patient testing or false elevated results.
Follow the cleaning steps in the technical bulletin to avoid reagent carryover. No replacement is needed if steps are followed.
Lot numbers 480483, 495947, 523902, and 536342.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2962-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2962-2020 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.
