FDA recall Z-0992-2019

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.

Reason for recall

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-01-22

Report date

2019-03-20

Termination date

2022-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2019