NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
This recall has been terminated (originally issued May 10, 2021).
- Recall Initiated
- May 10, 2021
- Terminated
- November 10, 2021
- Recall Number
- Z-2099-2021
- Quantity
- 71 kits US
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Lot / Code Info
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Root 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