Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

On September 23, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail instructing them to: - Discontinue use of and discard any of the product detailed above immediately or return remaining product to Randox Laboratories. - Review results generated with the affected batches in line with the clinical profile of the patient. - Discuss the contents of this notice with your Medical Director. - Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. - Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. On October 8, 2019 the firm distributed an amended Urgent Medical Device Recall. However, these letters were not identified as an Amended or Corrected notice. The notice is also still dated 09/23/2019. This updated notice identified the expiration date for the affected product as 28Mar2021. On October 16, 2019, the firm sent a second amended notice to customers via email.

Distribution

As reported by FDA

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