Randox Serology ToRCH lgM Positive Control Recall: Reduced HSV Reactivity Risk
Randox recalls Serology ToR: 2022 Positive Control kits due to reduced reactivity of HSV Type 1/2 lgM when tested on DiaSorin Liaison XL. Affected kits may give inaccurate results in lab tests for CMV, Rubella, Toxoplasma, and Herpes Simplex.
Lower-risk 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.
Contact the company
What happened, in plain English
Randox is recalling its Serology ToRCH lgM 2022 Positive Control kits because they may show reduced reactivity with Herpes Simplex Virus Type 1 and 2 when tested on the DiaSorin Liaison XL device. This could lead to inaccurate lab results for certain infections. Read more at govinfonow.com/recall/56943-randox-serology-torch-lgm-positive-control-recall-reduced-hsv-reactivity.
Source Summary by GovInfoNow · govinfonow.com/recall/56943-randox-serology-torch-lgm-positive-control-recall-reduced-hsv-reactivity · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0624-2024
Cite this page
“Randox Serology ToRCH lgM Positive Control Recall: Reduced HSV Reactivity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56943-randox-serology-torch-lgm-positive-control-recall-reduced-hsv-reactivity. Based on FDA recall #Z-0624-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0624-2024%22&limit=1).
Why it’s dangerous
The positive control kits may not react properly with the DiaSorin Liaison XL device, leading to inaccurate test results for Herpes Simplex Virus Type 1 and 2. This could cause false negatives in detecting these infections, potentially affecting patient diagnosis.
Who’s affected
Lab technicians and healthcare providers who use these kits for in vitro testing of IgM antibodies to CMV, Rubella, Toxoplasma, and Herpes Simplex Virus. Those most at risk are users who rely on these kits for accurate diagnostic results.
How to tell if you have this one
Check for the catalog number SR10349 or GTIN 05055273216424 on the kit label. The batch number starts with '157SR' and was produced in 2022.
- Brand
Randox- Product
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to- Category
Medical device
What to do — step by step
Check Kit Label
Look for the catalog number SR10349 or GTIN 05055273216424 on the kit label.
Where it went and when
Where it was distributed
Distributed in New York and West Virginia.
FDA distribution: “NY, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York, West Virginia.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this a safety hazard?
This is a low-risk issue related to potential inaccurate lab results, not a physical safety hazard like fire or injury.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0624-2024 (November 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0624-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.