Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0200-2024)

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 Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

Product Classification:

Class II

Date Initiated: September 6, 2023

Date Posted: November 8, 2023

Recall Number: Z-0200-2024

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: 35 units

Code Information:

GTIN: 05055273206104 Lot/Batch Number: (1) 7201-0747 7201-0423 7201-0417 7201-0353 7255-0198 7255-0172 7255-0171 7255-0129 7201-1085 7201-1086 7201-1079 7201-1080 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0482 (2)¿¿¿¿¿¿¿¿¿¿¿¿¿ 7201-0776 7201-0367 7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ 7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿

Distribution Pattern:

US Nationwide distribution including Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated