Randox Laboratories Ltd. Recall 88999
Description: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox Laboratories Ltd. Recall 88999 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0328-2022 |
| Event ID | 88999 |
| Event Description | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia. |
| Quantity | 15 kits |
| Recall 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 |
| Device Classification | 20211208 |
| Device Code Info | Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130 |
| Center Classification Date | 20211201 |
| Recall Initiation Date | 20211101 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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