Reported Nov 8, 2023 · Ongoing

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

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 Imola-IVD Clinical
  • Chemistry Analyzer Catalog NumberRX4900. RX4900R (refurbished)
Lot codes and dates
  • GTIN05055273206104
  • 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 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿
Amount recalled
35 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.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.