Nefa CAL recall
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Why was Nefa CAL recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
- Product
- NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 71 kits US
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
- Recall date
- July 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)