RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343… recallZ-0367-2020 · Randox Laboratories, Limited · initiated Sep 23, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories, Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0367-2020
- Status
- Terminated
- Initiated by the company
- Sep 23, 2019
- Recalling firm
- Randox Laboratories, Limited
- Quantity
- 212 (19 US; 193 OUS)
- Product code
- JLG
- Distribution
- WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
Product description
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Code information (models, lots, serial numbers)
Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Non-Esterified Fatty Acids (NEFA) FA115Randox Laboratories Limited · Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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