# FDA recall Z-1328-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2024-03-01.

## Product

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

Domestic: CA, FL, IL, ME, NJ, OH, & OR.

## Key facts

- **Recall number:** Z-1328-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-01
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2024

## Citation

> AI Analytics. FDA recall Z-1328-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1328-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*