Z-1328-2024 Class II Ongoing
FDA device recall Z-1328-2024 was initiated by Randox Laboratories Ltd. on March 1, 2024 and is designated Class II. Reason for recall: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. The recall status is ongoing. Affected quantity: 1,764 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- March 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,764 units
Product Description
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Reason for Recall
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Distribution Pattern
Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Code Information
Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)