Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling Randox Cholesterol kits (Catalog Number: CH2O0, Lot Number: 586177, expiring January 28, 2024) distributed nationwide in Maryland, Oregon, Puerto Rico, Montana, and West Virginia. The recall affects 15 kits because the product fails to meet its stated performance claims. When using the manual procedure with the kit's provided standard, the change in absorbance is lower than expected, which can generate internal quality control results that fall outside the acceptable range. Additionally, when using the instrument-specific application with the recommended calibration material CAL2351, the product's linearity performance is reduced by up to 35% compared to what is claimed on the kit insert, though quality control results may still appear within assigned ranges.
These performance failures may lead to delayed results for cholesterol testing. The source document does not specify what actions affected consumers or healthcare providers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Reason for recall: Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results. Distribution: Nationwide Distribution - MD, OR, PR, MT, WV Quantity: 15 kits Lot/code info: GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.