FDAMarch 16, 2015device
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 reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an ai...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
What to do
FDA enforcement status: Terminated
Brands named
diasorin
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
- 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 Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.2023-01-30
- FDASimplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v22023-01-30
- 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
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