[Recalled] Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 — Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) o… | FDA 20

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Randox Laboratories, Limited

• Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. — Class II
• Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. — Class II
• RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. — Class III
• RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. — Class II
• Magnesium on RX Imola analyser IVD — Class II
• Assayed Bovine Multi-Sera Level 1, Model No. AL1027 — Class III

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.