FDAFebruary 1, 2017device
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Or...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
3124010865683124010865691075875000946610758750004720
Recall history
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