FDAFDA · Food and drugs·Recall number Z-0753-2024
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Published January 24, 2024 · Recall initiated: November 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide including Puerto Rico.
- Lot
- GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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