Recall Z-2099-2021 ยท JLH Titrimetric, Fatty Acids
Randox Laboratories Ltd.
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
| Date | May 10, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " 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 |
| Quantity | 71 kits US |
| Distribution | US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.