Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0624-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: November 6, 2023

Date Posted: January 10, 2024

Recall Number: Z-0624-2024

Event ID: 93543

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.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

GTIN: 05055273216424 Bath/Lot Number: 157SR

Distribution Pattern:

NY, WV

Voluntary or Mandated:

Voluntary: Firm initiated