RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Randox Laboratories Ltd.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

Product Codes/Lot Numbers:

GTIN: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0198-2024

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