Recall Z-1328-2024
Randox Laboratories Ltd. · initiated March 1, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Codes / lots: 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)
Reason for recall
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
FDA-determined cause: Under Investigation by firm
Action taken
Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to technical.services@randox.com within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.
Details
- Recall number
- Z-1328-2024
- Initiated
- March 1, 2024
- Posted by FDA
- March 20, 2024
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 1,764 units
- Distribution
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North