Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
GTIN: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution including Puerto Rico
Recall record
- Recalling firm
- Randox Laboratories Ltd.
- Product type
- Devices
- Recall number
- Z-0202-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Crumlin (North), N/A
- Recall initiated
- 2023-09-06
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0202-2024 · Source: openFDA enforcement.