Recall Z-1424-2022 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Randox Laboratories Ltd.
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
| Date | Jun 22, 2022 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | Randox issued recall notification extended to the distribution center within the USA via email. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted week beginning 27 Jun 22. Letter states reason for recall, health risk and action to take: Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursemen |
| Quantity | 15 kits |
| Distribution | Nationwide Distribution - MD, OR, PR, MT, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923504 | CHOLESTEROL ENZYMATIC ENDPOINT Randox Laboratories, Ltd., Jan 10, 1994 |