Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with Recalled by Randox Laboratories Ltd. Due to A decrease in the reactivity of HSV Type...

Date: November 6, 2023
Company: Randox Laboratories Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.

Affected Products

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

Quantity: 1 unit

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 2 states: NY, WV

Affected (2 states)Not affected

About Randox Laboratories Ltd.

Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report