FDA recall Z-2202-2019

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

Reason for recall

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Distribution

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

Key facts

Status

Terminated

Initiation date

2019-06-17

Report date

2019-08-14

Termination date

2020-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2019