Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0202-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

Product Classification:

Class II

Date Initiated: September 6, 2023

Date Posted: November 8, 2023

Recall Number: Z-0202-2024

Event ID: 93102

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 13 units

Code Information:

GTIN: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA

Distribution Pattern:

US Nationwide distribution including Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated