DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 80567713190605F, 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Diasorin Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Product Codes/Lot Numbers:
UDI/DI 80567713190605F, 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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0677-2025
Related Recalls
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value