FDA Enforcement
Class II
Ongoing
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Recall: Z-0753-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0753-2024
- Event ID
- 93630
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 24, 2024
- Initiation Date
- November 20, 2023
- Classification Date
- January 18, 2024
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
Description
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Reason
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
Code Info
GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Distribution
US Nationwide including Puerto Rico.
Quantity
108 kits