SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in… — Class III medical device recall Z-0624-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-01-10, distributed in NY, WV. A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the
| Recall number | Z-0624-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2023-11-06 |
| Classified | 2024-01-02 |
| Reported by FDA | 2024-01-10 |
| Distributed | NY, WV |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 05055273216424 |
| Lot numbers | 157SR |
| Model numbers | SR10349 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0624-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.