Randox recalls Lipoprotein (a) assay for use on Roche Cobas c501 analyzers due to lack of 510(k) or PMA approval. Affected units have catalog number LP3403 and UDI-DI 05055273204421.
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Randox is recalling its Lipoprotein (a) assay for use on Roche Cobas c501 analyzers because it lacks required regulatory approval (510(k) or PMA). This could lead to inaccurate test results if used without proper clearance.
The assay lacks 510(k) or PMA approval, which are regulatory clearances needed for medical devices. Without these, the test results could be inaccurate, potentially leading to incorrect health decisions.
Healthcare professionals using Randox Lipoprotein (a) assays on Roche Cobas c501 analyzers are affected. Those with the catalog number LP3403 or UDI-DI 05055273204421 are most at risk.
Check for catalog number LP3403 or UDI-DI 05055273204421 on the product label. The recall applies to all lots within the product's expiration date.
Look for catalog number LP3403 or UDI-DI 05055273204421 on the product label.
The assay lacks required regulatory approval (510(k) or PMA) for use on Roche Cobas c501 analyzers, which could lead to inaccurate test results.
Check the product label for catalog number LP3403 or UDI-DI 05055273204421. If you have the affected product, contact Randox for guidance.
The recall applies to all lots within the product's expiration date, but no specific deadline is stated for action.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1017-2025 — Randox Randox Hello, I own a Randox that is covered by recall Z-1017-2025 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.
