RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0328-2022.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0328-2022.
Recall terminated by FDA.
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0328-2022.
Randox Laboratories Ltd.
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Randox Laboratories Ltd. Recall FAQ
Randox Laboratories Ltd. is the subject of a medical devices safety report: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200. The notice was published on November 1, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 15 units are potentially affected.