FDAFDA · Food and drugs·Recall number Z-1328-2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Published March 27, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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