RANDOX CHOL-cholesterol (total) test system intended to… recallZ-0328-2022 · Randox Laboratories Ltd. · initiated Nov 1, 2021

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 Ltd. 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

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

FDA root cause category: Under Investigation by firm

What the company is doing

Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " 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. " 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 organisation. If you have any questions or concerns please contact Randox Technical Services.

Recall details

Recall number: Z-0328-2022
Status: Terminated
Initiated by the company: Nov 1, 2021
Recalling firm: Randox Laboratories Ltd.
Quantity: 15 kits
Product code: CHH
FDA submissions: K923504
Distribution: US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.

Product description

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Code information (models, lots, serial numbers)

Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

CHOLESTEROL (CHOL) CH200
Randox Laboratories Limited
2 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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