Device product
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Z-0992-2019
Product summary
- Event
- Event 82113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1448
- Official record key
device-enforcement:Z-0992-2019
Official wording
Reason: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Code information: Lot 4221-0998-3223
Distribution pattern: US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.
Derived failure modes
-
Unknown
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.