FDAApril 14, 2023device
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and t...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
What to do
FDA enforcement status: Ongoing
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750006601
Recall history
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