Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
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
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273216424 Bath/Lot Number: 157SR
Products Sold
GTIN: 05055273216424 Bath/Lot Number: 157SR
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Randox issued Urgent Medical Device Correction Letter on 11/6/23 to the US Distributor Randox Laboratories-US, Ltd. , Kearneysville, West Virginia, for issuance to the user level. Letter states reason for recall, health risk and action to take: As the control material is still testing positive for HSV Type 1/2 lgM, there is no risk to health. If the control did test negative for this analyte, the affected run should be discarded, and the samples re-analysed. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFU and download the latest version from www.randox.com.alth risk and action to take: (
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY, WV
Page updated: Jan 10, 2026