Randox Lipase Assay Buffer Recalled for Imprecision in Quality Control
Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer 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, but the source text does not report any hospitalizations, injuries, or illnesses, 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 R1 Buffer. The affected products are identified by Catalogue Numbers LI011/004/UL and LI011/000/UL, and Lot Numbers 1048LI and 1050LI. These products were distributed worldwide, including nationwide distribution in the United States, Puerto Rico, and West Virginia.
The recall was initiated because Randox confirmed imprecision in quality control and patient samples when using these specific buffer batches. The Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
No specific instructions for consumers or healthcare providers are provided in the source text regarding disposal or replacement. Users of these specific lot numbers should be aware of the potential for imprecise results.
The recalled product
- Product
- Randox Lipase Assay: Lipase Colorimetric R1 Buffer - 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.
- Hazard
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)
- Catalogue Numbers: LI011/004/UL
- LI011/000/UL Lot #: 1048LI
- 1050LI
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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