Z-0624-2024 Class III Ongoing

Recalled by Randox Laboratories Ltd. — Crumlin (North), N/A

Recall Details

Product Type
Devices
Report Date
January 10, 2024
Initiation Date
November 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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

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 Pattern

NY, WV

Code Information

GTIN: 05055273216424 Bath/Lot Number: 157SR