medical Class II Updated 2019-08-14

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides-Product Code:1707801.

Recalled Product

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

Hazard / Issue

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572
View official government recall

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