FDAFDA · Food and drugs·Recall number Z-0752-2024
Calibration Serum Level 3 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
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide and Puerto Rico.
- Lot
- GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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