# FDA recall Z-0624-2024

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2023-11-06.

## Product

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2.  Catalog Number:  SR10349

## Reason for recall

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

## Distribution

NY, WV

## Key facts

- **Recall number:** Z-0624-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-06
- **Report date:** 2024-01-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0624-2024

## Citation

> AI Analytics. FDA recall Z-0624-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0624-2024. Source: US FDA. Licensed CC0.

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