FDADecember 13, 2023device
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
diasorin
UPCs
08056771600101
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens2024-11-07
- FDASimplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL14522023-06-14
- FDASimplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v22023-01-30
- FDASimplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.2023-01-30
- FDASimplexa Direct Amplification Disc Kit, Product Kit Code MOL14552021-11-19
- FDASIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 208161010270512021-09-23
- FDALIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia a...2020-11-23
- FDAParvovirus B19 IgG EIA kit Part No. V519IGUS2020-07-17
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →