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[Recalled] RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. — Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the perform… | FDA 2019-09-23

recall fda device united-kingdom

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductRANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Brand / manufacturerRandox Laboratories, Limited
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0367-2020
Country of noticeUnited Kingdom
Risk levelClass III
Hazard typerecall
Notice date23 September 2019
EAN / barcode05055273203066

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.

This Class III recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Randox Laboratories, Limited

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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