FDA recall Z-0624-2024

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

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

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