Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Reported: January 24, 2024 Initiated: November 20, 2023 #Z-0753-2024
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 108 kits
- Distribution
- US Nationwide including Puerto Rico.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351. Recalled by Randox Laboratories Ltd.. Units affected: 108 kits.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0753-2024.
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