Drug recall
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM…
FDA recall event 94187 · Class II · Randox Laboratories Ltd.
Key facts
| Event ID | 94187 |
|---|---|
| Recall numbers | Z-1328-2024 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| Initiation date | Mar 1, 2024 |
| Report date | Mar 27, 2024 |
| City | Crumlin (North) |
| Country | Ireland |
| FEI number | 2965 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: