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U.S. Department of Health and Human Services

Class 2 Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzer

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  Class 2 Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzer see related information
Date Initiated by Firm June 19, 2017
Create Date July 13, 2017
Recall Status1 Terminated 3 on August 14, 2018
Recall Number Z-2732-2017
Recall Event ID 77532
510(K)Number K151982  K141907  K142220  K131703  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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
Code Information All current software versions
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
For Additional Information Contact
781-647-3700
Manufacturer 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 2		 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 regarding this recall call 781-647-3700.
Quantity in Commerce 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = NOVA BIOMEDICAL CORPORATION
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