Diasorin Recalls
6 recalls on record · April 29, 2015 to December 18, 2024 · Medical Devices
Recalls by year
15
16
20
21
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 18, 2024Medical DevicesFDA
Diasorin Inc. recalls DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Hazard: 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.
January 31, 2024Medical DevicesFDA
Diasorin Inc. recalls DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Hazard: 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.
April 7, 2021Medical DevicesFDA
Diasorin Inc. recalls LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative
Hazard: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
September 9, 2020Medical DevicesFDA
Diasorin Inc. recalls Parvovirus B19 IgG EIA kit Part No. V519IGUS
Hazard: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
November 30, 2016Medical DevicesFDA
Diasorin Inc. recalls LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoa
Hazard: DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON¿ Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex).
April 29, 2015Medical DevicesFDA
Diasorin Inc. recalls DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA ki
Hazard: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.