Z-0753-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 kits
Product Description
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Reason for Recall
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
Distribution Pattern
US Nationwide including Puerto Rico.
Code Information
GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023