Randox Lipase Test System Recalled for Carryover Interference
Randox Laboratories is recalling 18 units of Lipase test kits due to carryover interference when run near LDL or Triglycerides assays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves a procedural error (carryover) rather than a direct physical or chemical hazard, and no injuries are reported, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Randox Laboratories Ltd. is recalling 18 units of the Randox Lipase (Colorimetric) test system. The recall is due to carryover observed when the Lipase test is run directly before or after LDL and Triglycerides assays. The affected products are identified by catalogue numbers LI3837, LI7979, LI8050, and LI8361.
The issue affects customers who purchased the Lipase kit in the USA. The firm has contacted all affected customers with updated instructions for use (IFU). Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not placed directly before or after LDL or Triglycerides.
The recalled product
- Product
- Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and…
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalogue number: LI3837
- LI7979
- LI8050
- LI8361
Distribution
Distributed nationwide across the United States.
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