Z-0752-2024 Class II Ongoing
FDA device recall Z-0752-2024 was initiated by Randox Laboratories Ltd. on November 20, 2023 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 269 kits.
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
- 269 kits
Product Description
Calibration Serum Level 3 CAL2351
Reason for Recall
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%.
Distribution Pattern
US Nationwide and Puerto Rico.
Code Information
GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE