Diasorin recalls
Diasorin appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2024-12-18.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2015-04-29 to 2024-12-18 |
| By agency | FDA Device (6) |
| By classification | Class II (6) |
| By status | ongoing (3), terminated (3) |
| Distribution named in notices | CA, CT, IL, MA, MI, MN, NC, NJ, NY, US, VA, WI |
Recalls
- DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060
FDA Device · Class II · 2024-12-18 · Diasorin
Reason: 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 cl… - DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
FDA Device · Class II · 2024-01-31 · Diasorin
Reason: 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 equi… - LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of p…
FDA Device · Class II · 2021-04-07 · Diasorin
Reason: Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. - Parvovirus B19 IgG EIA kit Part No. V519IGUS
FDA Device · Class II · 2020-09-09 · Diasorin
Reason: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value - LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended f…
FDA Device · Class II · 2016-11-30 · Diasorin
Reason: 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… - DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reag…
FDA Device · Class II · 2015-04-29 · Diasorin
Reason: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.