Randox recalls two lipase test kits (LI3837 and LI8361) for potential contamination in lab testing of pancreatic diseases. Affected kits may cause inaccurate results if used on medical devices.
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Randox is recalling two specific lipase test kits used in medical labs for pancreatic disease testing. The recall is due to a risk of contamination that could lead to inaccurate test results if the kits are used on certain medical devices.
The lipase test kits can become contaminated if used on certain medical devices, potentially causing inaccurate test results. This contamination risk is specific to laboratory settings where the kits are used for professional medical testing.
Healthcare professionals using these lipase test kits in medical labs are most at risk. The kits are used for testing pancreatic diseases like acute pancreatitis.
Check for catalog numbers LI3837 (GTIN: 05055273204230) or LI8361 (GTIN: 05055273214284). The kits are used for professional testing of pancreatic diseases in medical labs.
Look for catalog numbers LI3837 or LI8361 on the product label.
Randox has identified a risk of contamination that could lead to inaccurate test results when these lipase kits are used on certain medical devices.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates a potential contamination risk in lab settings, but the kits are designed for professional use in medical testing.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-1631-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
