Device product
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Z-1328-2024
Product summary
- Event
- Event 94187
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,764 units
- Official record key
device-enforcement:Z-1328-2024
Official wording
Reason: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
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)
Distribution pattern: Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Derived failure modes
-
Unknown
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.