---
title: "Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators use... — FDA record Z-1328-2024 | Is It on Recall"
description: "The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC."
url: https://isitonrecall.com/recall/fda-device-z-1328-2024-liquid-protein-calibrators-c3-and-haptoglobin-liquid-protein-calibrators-used-with-randox-iga-igg-an/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays t... — FDA record Z-1328-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
- **Reason**: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- **Classification**: Class II
- **Recalling firm**: Randox Laboratories Ltd.
- **Quantity**: 1,764 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1328-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1328-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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) |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Maine](https://isitonrecall.com/state/maine/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Mar 27, 2024
- **Recall initiation date**: Mar 1, 2024
- **Center classification date**: Mar 20, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1328-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Randox Laboratories Ltd. records](https://isitonrecall.com/brand/randox-laboratories-ltd/)