NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Reported: July 28, 2021 Initiated: May 10, 2021 #Z-2099-2021
Product Description
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 71 kits US
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115. Recalled by Randox Laboratories Ltd.. Units affected: 71 kits US.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2099-2021.
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