SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use… recallZ-0624-2024 · Randox Laboratories Ltd. · initiated Nov 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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 [email protected] 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: (
Recall details
- Recall number
- Z-0624-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 6, 2023
- Posted by the FDA
- Jan 2, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 unit
- Product code
- OHQ
- Distribution
- NY, WV
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
Code information (models, lots, serial numbers)
GTIN: 05055273216424 Bath/Lot Number: 157SR
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) SR10349Randox Laboratories Limited · Multi-Analyte Controls Unassayed1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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