Recall Z-0328-2022 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
| Date | Nov 1, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the respon |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923504 | CHOLESTEROL ENZYMATIC ENDPOINT Randox Laboratories, Ltd., Jan 10, 1994 |