FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
- Recall number
- Z-2099-2021
- Recalling firm
- Randox Laboratories Ltd.
- Product
- NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
- Status
- Terminated
- Initiated
- 2021-05-10
- Posted
- not on file
- Terminated
- 2021-11-10
- Reason
- 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
- 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
- 71 kits US
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
- Lot, serial or model codes
- Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JLH
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28