Z-2099-2021Class II

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

Name: Z-2099-2021 NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Creator: Randox Laboratories Ltd.
Published: 2021-05-10
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2021-05-10 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 on 2021-05-10. FDA classified it as Class II and gives the reason as "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". 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-2099-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-10
Posted: 2021-07-20
Terminated: 2021-11-10
Recalling firm: Randox Laboratories, Limited
Product: NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Product code: JLH Titrimetric, Fatty Acids
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " 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
Quantity in commerce: 71 kits US
Distribution: US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Product codes and lots: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2099-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2099-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-20

Product code JLH

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)