Randox Laboratories Ltd. Recall 88130
Description: NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Randox Laboratories Ltd. Recall 88130 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2099-2021 |
| Event ID | 88130 |
| Event Description | NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX |
| Quantity | 71 kits US |
| Recall Reason | Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples |
| Device Classification | 20210728 |
| Device Code Info | Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066 |
| Center Classification Date | 20210720 |
| Recall Initiation Date | 20210510 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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