Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Product Codes/Lot Numbers:
GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1593-2024
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