The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT & WA.
Description du dispositif
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Nationwide, including: PA, MI, NY, OH, NJ, TX, AL, MO, AR, TN, WA, KY, and NC, and London, ON, Canada
Description du dispositif
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.