DiaSorin recalls MOL3650 Simplexa VZV Direct due to software issues causing false negatives in VZV DNA tests. Affected units have specific lot numbers and release dates. Contact for remedy.
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
DiaSorin is recalling its MOL3650 Simplexa VZV Direct test kit because a software glitch may cause false negative results in VZV DNA tests. This could lead to missed diagnoses of serious viral infections in patients with central nervous system symptoms.
The software malfunction in the Multi Assay Suite can cause the test to produce false negative results. This means the test might incorrectly show no VZV DNA when it is actually present, potentially missing serious infections.
Healthcare providers using the MOL3650 Simplexa VZV Direct test kit on LIAISON MDX instruments are most at risk. Patients with suspected central nervous system VZV infections may be affected if the test is used incorrectly.
Check the lot number on the product label. Affected units have lot numbers 5178N (released June 2019) or 7004N (released March 2020).
Look for lot numbers 5178N or 7004N on the product label.
The software malfunction may cause false negative results, meaning the test could miss VZV DNA when it is present, potentially leading to missed diagnoses.
Check the lot number on the product label. Affected units have lot numbers 5178N (released June 2019) or 7004N (released March 2020).
The recall record does not specify a remedy, so contact DiaSorin directly for guidance.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-2548-2020 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-2548-2020 from DiaSorin. 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.
