Reported Jan 29, 2025 · Ongoing
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog…
Randox Laboratories, Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories, Limited · Ardmore; 55 The Diamond Road · Crumlin · N/A
Is this the product you have?
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers
- Catalog NumberLP2757
- Lot codes and dates
- UDI-DI05055273209198 All lots within expiry
- Amount recalled
- 33 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Randox Laboratories, Limited recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.