DiaSorin recalls Simplexa Direct Amplification Disc Kit (MOL1455) due to potential leakage when reused, risking lab cross-contamination. Affected lots listed in product details.
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
DiaSorin is recalling a specific batch of Simplexa Direct Amplification Disc Kits because some discs can leak when reused with certain COVID-19 and flu tests. This leakage could cause cross-contamination in labs if not properly cleaned after a positive sample.
Leakage from a well containing a positive sample can occur when a disc is reused with Simplexa COVID-19 Direct or Simplexa Flu A/B & RSV Direct Gen II tests. This leakage may spread the sample to other areas of the lab if not cleaned properly after testing.
Lab technicians and users who have the specific kit lots listed in the recall notice are most at risk. The hazard applies only to the discs used more than once with certain test kits.
Check the kit lot numbers listed: 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N (disc lot numbers also listed). The kit contains 3 discs with product code MOL1452.
Look for the kit lot numbers listed in the recall notice: 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N.
The recall is for a subset of discs that may leak when reused with certain Simplexa tests, risking cross-contamination in labs if not cleaned properly.
Affected kit lots include 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13369N, 13370N, 13434N, 13652N, and 13242N (disc lot numbers also listed).
Yes, but only once per test. Reusing them may cause leakage and cross-contamination if not cleaned properly after a positive sample.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-0457-2022 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-0457-2022 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.
