Z-0367-2020Class III

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

Name: Z-0367-2020 RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066
Creator: Randox Laboratories, Limited
Published: 2019-09-23
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-09-23 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories, Limited began a recall of RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066 on 2019-09-23. FDA classified it as Class III and gives the reason as "Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0367-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-23
Posted: 2019-11-13
Terminated: 2020-05-07
Recalling firm: Randox Laboratories, Limited
Product: RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Product code: JLG Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Reason for recall: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected] 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.
Quantity in commerce: 212 (19 US; 193 OUS)
Distribution: WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
Product codes and lots: Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0367-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0367-2020	Class III	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-13

Product code JLG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)