Randox Laboratories Ltd. has recalled one unit of its SEROLOGY ToRCH IgM 2022 POSITIVE CONTROL (Catalog Number SR10349). This product is a lab control used to ensure that diagnostic tests for various infections, including Herpes Simplex Virus (HSV), are working correctly. The recall was issued because the HSV Type 1/2 IgM component shows decreased reactivity when tested on the DiaSorin Liaison XL system, which could lead to inaccurate laboratory results. This specific unit was distributed to facilities in New York and West Virginia.
The reduced reactivity of the positive control means that diagnostic tests for Herpes Simplex Virus Type 1 and 2 may not be properly validated during laboratory runs. This creates a risk that the testing system could produce incorrect or unreliable results for patients being screened for these infections.
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Sources: FDA iRES · Raw API Response
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