Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples
Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent 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, and the source text describes a quality control issue (imprecision) without reporting any specific injuries, illnesses, 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 Reagent. This medical device is intended for the quantitative in vitro determination of Lipase in human serum and plasma. The recall involves 2,219 kits 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 specific reagent batches. The affected products are identified by Catalogue Numbers LI3837, LI7979, LI8050, and LI8361, and specific GTINs and Lot numbers are listed in the agency's recall record.
Healthcare facilities and laboratories should stop using the affected reagent batches and contact Randox Laboratories for further instructions. Consumers are not directly affected as this is an in vitro diagnostic device used by medical professionals.
The recalled product
- Product
- Randox Lipase Assay: Lipase Colorimetric Reagent - 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.
- Affected units
- 2,219
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 (11)
- Catalogue Numbers: LI3837
- LI7979
- LI8050
- LI8361 GTIN: 05055273204230
- 05055273204247
- 05055273209136
- 05055273214284 Lot #: 507360
- 497086
- 497053
- 497038
- 502135
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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