DiaSorin recalls MOL3655 Simplexa VZV Swab Direct for potential false negative results from a software malfunction in the Multi Assay Suite. Affected lots were sold between September 2019 and February 2021.
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 MOL3655 Simplexa VZV Swab Direct product because a software issue in the Multi Assay Suite could cause false negative results. This means tests might incorrectly show no virus when it's actually present, which could lead to missed diagnoses.
The software malfunction in the Multi Assay Suite can cause the test to show a negative result when the virus is actually present. This might lead to missed diagnoses of varicella-zoster virus infections, which can be serious if untreated.
Healthcare providers using the MOL3655 Simplexa VZV Swab Direct for VZV testing on the LIAISON MDX instrument are likely affected. Patients with suspected varicella-zoster virus infections are at risk of incorrect test results.
Check the lot number on the product label. Affected lots include 5743N (released Sept 2019, expires Sept 2020), 5819N (released Oct 2019, expires Oct 2020), and 5820N (released Feb 2020, expires Feb 2021).
Look for the lot number on the product label to determine if it's affected (5743N, 5819N, or 5820N).
The recall record states there is a software malfunction in the Multi Assay Suite that increases the probability of false negative results, but does not specify the exact issue.
Check the lot number on the product label. Affected lots are 5743N (released Sept 2019), 5819N (released Oct 2019), and 5820N (released Feb 2020).
The recall record does not specify a remedy, so there is no action required beyond checking the lot number.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-2549-2020 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-2549-2020 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.
