Nova Biomedical Corporation recalls Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile

Recalled July 19, 2017 · FDA recall Z-2732-2017 · Nova Biomedical

Hazard

Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. · FDA Class II

Units

179 units (US) and 904 (OUS) Total 1083

Sold at

Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana Greece Guatemala Guyana Honduras Hong Kong Hungary ICELAND India Iran Israel Italy Ivory Coast Japan Jordan Kenya Korea Latvia Macedonia Malaysia Mexico Nepal Netherlands Nigeria Pakistan Pakistan Palestine Peru Philippines Poland Puerto Rico Republic of Panama Republica Dominicana Russia Saudi Arabia Slovak Republic Slovenia South Africa Sri Lanka Switzerland Taiwan Thailand The Netherlands Trinidad,W.I. Tunisia Turkey UK Uruguay Vietnam

Description

Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

Product

Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

Manufacturer(s)

Nova Biomedical Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →