Randox recalls Lipoprotein (a) assay for Roche Cobas c501 analyzers due to missing 510(k) or PMA certification. Affected units have catalog number LP2757 and UDI-DI 05055273209198.
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 with 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 certification.
The assay lacks necessary regulatory approval (510(k) or PMA) for use with Roche Cobas c501 analyzers. This means it might not meet safety and accuracy standards, potentially causing incorrect blood test results.
Healthcare providers using the Randox Lipoprotein (a) assay on Roche Cobas c501 analyzers are affected. Patients relying on these tests for blood lipid analysis may be at risk of inaccurate results.
Check for catalog number LP2757 and UDI-DI 05055273209198 on the product label. The recall applies to all units within their expiration date.
Look for catalog number LP2757 and UDI-DI 05055273209198 on the product label.
The recall indicates the product lacks required regulatory approval, so it may not be safe for use with Roche Cobas c501 analyzers.
The recall record does not specify a remedy, so contact Randox directly for guidance.
Check for catalog number LP2757 and UDI-DI 05055273209198 on the product label. The recall applies to all units within their expiration date.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1018-2025 — Randox Randox Hello, I own a Randox that is covered by recall Z-1018-2025 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.
