Device 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
Z-2202-2019
Product summary
- Event
- Event 83228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1099 (5 pack x 60)=329700 slides
- Official record key
device-enforcement:Z-2202-2019
Official wording
Reason: Potentially Biased Results using VITROS Chemistry Products GLU Slides
Code information: Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572
Distribution pattern: US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Derived failure modes
-
Unknown
Potentially Biased Results using VITROS Chemistry Products GLU Slides