Diasorin recalls LIAISON Q.S.E.T. Device Plus (REF 319060) due to loose caps causing buffer leaks. This may lead to incorrect stool test results. Affected units include specific lot numbers for stool specimen preparation.
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Diasorin is recalling LIAISON Q.S.E.T. Device Plus devices that may have loose clear caps, causing buffer leaks. This can result in incorrect stool test results if used improperly. The recall affects specific lot numbers sold for human stool specimen preparation.
Loose clear caps in 0.14% of the recalled devices may allow buffer to leak from the tube. This can cause insufficient buffer volume, leading to incorrectly high patient test results for stool specimens.
Laboratory users preparing human stool specimens with the recalled LIAISON Q.S.E.T. Device Plus devices are most at risk. The recall impacts specific lot numbers produced between 2020 and 2023.
Check for the product name 'LIAISON Q.S.E.T. Device Plus' with reference number 319060. Affected units include specific lot numbers listed in the recall notice for stool specimen preparation.
Look for the lot numbers 225084, 232094, 234114, 259144, 221214, 252244, 230094, 224124, 205144, 228174, 228224, 223274, 219104, 217134, 233154, 236174, 224244, 232294, 229224, 251234, 221294, 210204, 223244, 222314 on the device.
Diasorin found that 0.14% of the LIAISON Q.S.E.T. Device Plus devices have loose clear caps, which may cause buffer leaks and incorrect stool test results.
Check the lot number on your device. If it matches the listed numbers, stop using it and contact Diasorin for further instructions.
The recall does not provide a fix; affected devices must be checked and potentially discarded if the lot number matches.
We’ve drafted a message you can send Diasorin to request your refund or repair — edit it as you like.
Subject: Recall Z-0677-2025 — Diasorin Diasorin Hello, I own a Diasorin that is covered by recall Z-0677-2025 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.
