Recall Z-0815-2024— Diasorin Inc.

Name: FDA recall Z-0815-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Class II · Ongoing

Class II FDA medical device recall by Diasorin Inc., initiated 2023-12-13. It names one FDA 510(k) clearance: K081687. Product: DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620. 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 equivocal and/or false positive results..

Recalling firm: Diasorin Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-13
Firm location: Stillwater, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGGDiaSorin, Inc.·cleared 2008-11-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.