FDA Device recall Z-0624-2024
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV…
- FDA Device
- Class III
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class III recall of SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV… by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0624-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-11-06 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Randox Laboratories |
| Distribution | NY, WV |
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
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.
Identifiers
| code_info | GTIN: 05055273216424 Bath/Lot Number: 157SR |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0624-2024%22
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