DiaSorin recalls Simplexa Flu A/B & RSV Direct Gen II tests that may leak, causing contamination and invalid results. Affected units include specific lot numbers from 2023.
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
DiaSorin is recalling Simplexa Flu A/B & RSV Direct Gen II tests because they can leak during use, leading to cross-contamination and incorrect results. This affects users who have the specific lot numbers listed in the recall notice.
The test discs used with these products may leak during the testing process. This leakage can cause cross-contamination of samples and lead to invalid results or error codes on the device.
Users of the Simplexa Flu A/B & RSV Direct Gen II tests with the specific lot numbers listed in the recall notice are affected. Laboratory staff and home users who have the affected products are most at risk.
Check the product label for the lot numbers: MOL2655/13648N, MOL2655/13882N, or MOL2655/15279N with corresponding Reaction Mix lot numbers. The product includes a unique identifier (UDI-DI: 20816101026962).
Look for the lot numbers MOL2655/13648N, MOL2655/13882N, or MOL2655/15279N on the test disc and Reaction Mix.
Check the product label for the specific lot numbers listed in the recall notice. If you have the affected lot numbers, contact DiaSorin for instructions.
The tests may leak, causing cross-contamination and invalid results, but there is no mention of serious injury risk in normal use.
Check the product label for lot numbers MOL2655/13648N, MOL2655/13882N, or MOL2655/15279N with corresponding Reaction Mix lot numbers.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-1210-2023 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-1210-2023 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.
