Randox Lipase Assay Recalled for Potential Contamination on Rx Instruments
Randox Laboratories is recalling Lipase Assay kits due to potential contamination risks on Rx instruments. The recall affects specific lots distributed in West Virginia and Puerto Rico.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a precautionary measure to avoid contamination without reporting specific injuries or illnesses, aligning with a Moderate severity rating.
Plain-English summary
Randox Laboratories Ltd. is recalling specific lots of Lipase Assay kits, catalog numbers LI3837 and LI8361. The recall involves eight units of the product, which is used for the quantitative in vitro determination of Lipase in human serum and plasma to help diagnose pancreatic diseases.
The recall was initiated because Randox has released further steps to avoid contamination of the Lipase Assay on Rx instruments. The affected lot numbers are 428000, 404175, and 404245. The product was distributed nationwide in the United States, specifically in the states of West Virginia and Puerto Rico.
Healthcare professionals and laboratories using these specific lots should stop using the product and follow the instructions provided by Randox to avoid contamination issues. Consumers are not directly affected as this is a professional-use in vitro diagnostic product.
The recalled product
- Product
- Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and…
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 8
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 (3)
- Lot numbers: 428000
- 404175
- and 404245
Distribution
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