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.
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.
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.
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.
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.
Check for the catalog number SR10349 or GTIN 05055273216424 on the kit label. The batch number starts with '157SR' and was produced in 2022.
Look for the catalog number SR10349 or GTIN 05055273216424 on the kit label.
The recall is happening because the positive control kits may show reduced reactivity with Herpes Simplex Virus Type 1 and 2 when tested on the DiaSorin Liaison XL device, which could lead to inaccurate lab results.
The official recall notice does not specify a remedy or action for affected kits. Check the kit label for the catalog number SR10349 or GTIN 05055273216424 to confirm if it is affected.
This is a low-risk issue related to potential inaccurate lab results, not a physical safety hazard like fire or injury.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0624-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0624-2024 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
