Randox recalls all CYSC Cystatin C reagents for IVD use due to missing FDA 510(k) clearance. This affects lab tests requiring the reagent. No action needed as the product is not for consumer use.
Cystatin C Reagent marketed without a 510 (k)
Rando: Randox Laboratories recalls all CYSC Cystatin C reagents used in lab tests because they were marketed without the required FDA 510(k) clearance. This means the reagents are not approved for in vitro diagnostic use, but they do not pose a direct risk to consumers.
The reagents were sold without the necessary FDA 510(k) clearance, which is a regulatory approval for medical devices. This means they are not officially approved for use in lab tests, but they do not cause immediate harm to users.
Lab technicians and healthcare facilities using the reagents for in vitro diagnostics. The risk is low as the product is not for consumer use.
Check for the catalogue number CYS4004 or GTIN 05055273208665 on the reagent packaging. All lots of this product are affected.
Verify the catalogue number CYS4004 or GTIN 05055273208665 on the reagent packaging.
The reagents are not approved for in vitro diagnostic use due to missing FDA 510(k) clearance, but they do not pose a direct risk to consumers.
No action is needed as the product is not for consumer use and the hazard is low risk.
Check the product details to confirm it is affected; no specific action is required.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2425-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-2425-2024 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
