Recall Z-2732-2017— Nova Biomedical Corporation
Class II · Terminated
Class II FDA medical device recall by Nova Biomedical Corporation, initiated 2017-06-19, terminated 2018-08-14. It names 4 FDA 510(k) clearances: K151982, K141907, K142220 and 1 more. 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. 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..
- Recalling firm
- Nova Biomedical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-19
- Terminated
- 2018-08-14
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
4 on FDA's record- K151982 — Stat Profile Prime ABG Analyzer System
- K141907 — STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
- K131703 — NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.