Lower riskMedical device recall · FDA · Published March 2, 2018
Randox Lipase Test Kits: Contamination Risk in Lab Use
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 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. Read more at govinfonow.com/recall/71816-randox-lipase-test-kits-contamination-risk-in-lab-use.
“Randox Lipase Test Kits: Contamination Risk in Lab Use.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71816-randox-lipase-test-kits-contamination-risk-in-lab-use. Based on FDA recall #Z-1631-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2018%22&limit=1).
The FDA announced on March 2, 2018, that Randox Laboratories Ltd. voluntarily recalled Lipase assay kits to prevent contamination risks on Rx instruments. The agency issued recall number Z-1631-2018 for the affected professional-use diagnostic products.
How to tell if you have it
Brand: Randox
Product: Lipase
Catalog numbers: LI3837 and LI8361
GTINs/UPCs: 05055273204230 and 05055273214284
Lot codes: 428000, 404175, and 404245
The hazard
The recall addresses the risk of contamination of the Lipase Assay when used on Rx instruments. The FDA stated that Randox released further steps to avoid this contamination issue.
Context
GovInfoNow's records show Randox Laboratories Ltd. has had 49 other recalls since June 7, 2017. Recent brand recalls include a March 5, 2024 recall for Clinical Chemistry Calibration Serum due to an inorganic phosphate bias issue and an April 5, 2024 recall for Evidence MultiSTAT Software v3.7 involving light leak risks. Other recent recalls of similar products include Instrumentation Laboratory Coagulation Test Kits (Dec. 11, 2025) and Medline Blood Culture Kit (Dec. 24, 2025).
How to tell if you have this one
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.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution in the states of West Virginia 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 13 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-1631-2018 (March 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1631-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.