Recall Z-2099-2021
Randox Laboratories Ltd. · initiated May 10, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Codes / lots: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-2099-2021
- Initiated
- May 10, 2021
- Terminated
- November 10, 2021
- Product code
- JLH – Titrimetric, Fatty Acids
- Quantity
- 71 kits US
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North