Recall Z-0624-2024— Randox Laboratories Ltd.
Class III · Ongoing
Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2023-11-06. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-11-06
- Firm location
- Crumlin (North), N/A, Ireland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.