Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving an in vitro diagnostic device with performance failures that could affect test reliability. While no illnesses or injuries have been reported and quality control results still fall within acceptable ranges for the instrument-specific application, the manual procedure shows quality control failures, and the product fails to meet its stated performance claims.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Cholesterol diagnostic kits (Catalog Number CH2O0, Lot 586177, expiry 28 January 2024) used in laboratory testing for cholesterol measurement in serum and plasma.
The kits fail to meet their stated performance specifications. In the manual procedure, the change in absorbance during calibration is lower than expected, causing internal quality control results to fall outside the acceptable range. In the instrument-specific application using calibration material CAL2351, the linearity performance is reduced by up to 35% compared to the kit's stated claims. These issues may lead to delayed test results.
The affected kits were distributed nationwide to locations in Maryland, Oregon, Puerto Rico, Montana, and West Virginia. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 15
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 (1)
- GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024
Distribution
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