DiaSorin recalls SIMPLEXA COVID-19 Positive Control Packs with unapproved materials that may cause delayed amplification signals. Affected units include specific lot numbers and expiration dates.
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
DiaSorin is recalling certain SIMPLEXA COVID-19 Positive Control Packs due to unapproved materials that could cause delayed amplification signals. This affects lab tests used for COVID-19 testing and may lead to inaccurate results.
The control packs contain unapproved raw materials that may cause delayed amplification signals during testing. This could lead to inaccurate test results if the control pack fails to function properly.
Lab technicians and healthcare facilities using the recalled SIMPLEXA COVID-19 Positive Control Packs for testing. Those most at risk are users who rely on these control packs for accurate test results.
Check the lot number and expiration date on the packaging. Affected units include lot numbers 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, and X12724N/08.31.2022.
Review the lot number and expiration date on the packaging to confirm if it matches the affected units listed.
The SIMPLEXA COVID-19 Positive Control Packs contain unapproved raw materials that may cause delayed amplification signals, potentially leading to inaccurate test results.
Check the lot number and expiration date on the packaging. If it matches the affected units, contact DiaSorin for guidance.
The recall is for potential inaccurate test results, not direct safety risks to users. The hazard is low risk as it does not cause injury.
We’ve drafted a message you can send DiaSorin to request your refund or repair — edit it as you like.
Subject: Recall Z-0162-2022 — DiaSorin DiaSorin Hello, I own a DiaSorin that is covered by recall Z-0162-2022 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.
