Serology ToRCH positive control specimen recalled for decreased HSV reactivity
Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class III recall involves a diagnostic control specimen with reduced reactivity that could affect test performance. No illnesses, injuries, or deaths have been reported. Per the severity rubric, Class III recalls with theoretical hazards and no reported harm are typically scored 1–2; this is rated Moderate (2) due to potential impact on diagnostic accuracy.
Plain-English summary
Randox Laboratories Ltd. is recalling the SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Catalog Number SR10349, Lot 157SR). This medical device is a positive control specimen used in laboratory testing to verify the performance of in vitro diagnostic assays for IgM antibodies to Cytomegalovirus, Rubella Virus, Toxoplasma gondii, and Herpes Simplex Virus Types 1 and 2.
The recall was initiated because the product exhibits decreased reactivity of HSV Type 1/2 IgM when tested on the DiaSorin Liaison XL analyzer. A positive control specimen is used to ensure that diagnostic tests are functioning correctly; reduced reactivity could compromise the reliability of test results.
The affected product was distributed in New York and West Virginia. Laboratory personnel and healthcare providers using Lot 157SR should discontinue use and contact Randox Laboratories Ltd. or the FDA for guidance on replacement and verification procedures.
The recalled product
- 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…
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273216424 Bath/Lot Number: 157SR
Distribution
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