Recall Z-2732-2017 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Nova Biomedical Corporation
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-Oximet
| Date | Jun 19, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 reg |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM Nova Biomedical Corporation, Mar 25, 2014 |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG Nova Biomedical Corporation, May 29, 2015 |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) Nova Biomedical Corporation, Oct 17, 2014 |
| K151982 | Stat Profile Prime ABG Analyzer System Nova Biomedical Corporation, Sep 10, 2015 |