Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control
Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.
What this means for you
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. The source text identifies a quality control issue (imprecision) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Randox Laboratories, Ltd. is recalling specific batches of the Randox Lipase Assay: Lipase Colorimetric R2 Substrate. The product is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
The recall was initiated because Randox confirmed imprecision in quality control and patient samples when using specific batches of the Randox Lipase R2 Substrate. The affected catalogue numbers are LI015/000/UL and LI015/003/UL, with lot numbers 1049LI and 1051LI.
The product was distributed worldwide, including nationwide distribution in the United States, Puerto Rico, and West Virginia. Users should check their inventory for the specific catalogue and lot numbers listed and stop using the affected product.
The recalled product
- Product
- Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
- Manufacturer
- RANDOX LABORATORIES, LTD.
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 Numbers: LI015/000/UL
- LI015/003/UL
- LI015/000/UL Lot #: 1049LI
- 1051LI
Distribution
Part of a larger recall action
This product is one of 3 recalled by RANDOX LABORATORIES, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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