Recall Z-2732-2017
Nova Biomedical Corporation · initiated June 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All current software versions
Reason for recall
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-determined cause: Software design
Action taken
Nova Biomedical issued Urgent Field Correction Notice on June 19, 2017, to all affected customers. The letter advises users of the problem and Nova Biomedical or an authorized Nova Biomedical representative will schedule a no charge update of your Stat Profile Prime Analyzer software to version VI1.0.883.0. A representative will contact customers to schedule this update. Questions: contact Nova Biomedical Technical Support at 1-800-545-6682, in Canada contact us at 1-800-263-5999, or outside of N. America contact your authorized Nova Biomedical subsidiary or distributor. For questions regarding this recall call 781-647-3700.
Details
- Recall number
- Z-2732-2017
- Initiated
- June 19, 2017
- Terminated
- August 14, 2018
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 179 units (US) and 904 (OUS) Total 1083
- Distribution
- 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…
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA