Device product
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Z-0753-2024
Product summary
- Event
- Event 93630
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 108 kits
- Official record key
device-enforcement:Z-0753-2024
Official wording
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 information: GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Distribution pattern: US Nationwide including Puerto Rico.
Derived failure modes
-
Unknown
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