FDANovember 7, 2024device
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
diasorin
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiaSorin LIAISON HSV-2 Type Specific IgG, REF 3106202023-12-13
- 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
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