Reported Jul 28, 2021 · Terminated
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard
- for measurement of NEFA Catalog NumberFA115
- Lot codes and dates
- Batch Number544642 Exp
- Date28th
- Nov 2022 GTIN05055273203066
- Amount recalled
- 71 kits US
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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