Reported Nov 8, 2023 · Ongoing
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Randox Laboratories Ltd.
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 Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- RX Monaco-IVD Clinical
- Chemistry Analyser Catalog NumberRX5000
- Lot codes and dates
- GTIN05055273207750 Lot/ Batch Number
230T240CS0126S210T240CS0258SS180T240CS0486MAS180T240CS0487MAS180T240CS0483MAS180T240CS0218MAS170T240CS0665MAS160T240CS0111MAS160T240CS0110MAS150T240CS0005MAS140T240CS0185MAS140T240CS0017MAS140T240CS0015MA
- GTIN05055273207750 Lot/ Batch Number
- Amount recalled
- 13 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
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 Ltd. 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.