Z-2202-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- June 17, 2019
- Termination Date
- November 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1099 (5 pack x 60)=329700 slides
Product Description
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 Pattern
US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Code Information
Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572