Diasorin Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Diasorin Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-12-18FDA-DeviceClass IIDiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
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.
- 2024-01-31FDA-DeviceClass IIDiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
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.
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