Reported Nov 20, 2019 · Terminated

RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

Randox Laboratories, Limited

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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, Limited · Ardmore; 55 The Diamond Road · Crumlin, N/A · N/A

Is this the product you have?

  • RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343
  • GTIN5055273203066
Lot codes and dates
  • Catalogue numberFA115
  • GTIN05055273203066
  • Batch/Lot485343
  • ExpMar 2019
Amount recalled
212 (19 US; 193 OUS)

Where it was sold

Why it was recalled

Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 7, 2020 · Data as of Sep 19, 4:44 PM UTC

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