Randox Cholesterol- For the quantitative in vitro… recallZ-1424-2022 · Randox Laboratories Ltd. · initiated Jun 22, 2022

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

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

FDA root cause category: Process design

What the company is doing

Randox issued recall notification extended to the distribution center within the USA via email. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted week beginning 27 Jun 22. Letter states reason for recall, health risk and action to take: 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.

Recall details

Recall number: Z-1424-2022
Status: Terminated
Initiated by the company: Jun 22, 2022
Recalling firm: Randox Laboratories Ltd.
Quantity: 15 kits
Product code: CHH
FDA submissions: K923504
Distribution: Nationwide Distribution - MD, OR, PR, MT, WV

Product description

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

Code information (models, lots, serial numbers)

GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024

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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