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Open, Classified

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

FDA Recall Z-1017-2025 · Posted 2025-01-23

Recalling FirmRandox Laboratories, Limited
Recall StatusOpen, Classified
Product CodeDFC
Date Initiated2024-12-20
Product Quantity15 kits

Reason for Recall

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Firm Action

Randox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution Including PR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011568RANDOX LIPOPROTEINRandox Laboratories, Ltd. · 2001-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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