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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJanuary 27, 2006
Date PostedFebruary 28, 2006
Recall Status1 Terminated 3 on October 19, 2006
Recall NumberZ-0577-06
Recall Event ID 34522
510(K)NumberK022746 
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
ProductStat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413
Code Information All S/N''s
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
For Additional Information ContactPaul W. MacDonald
781-894-0800
Manufacturer Reason
for Recall		Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
FDA Determined
Cause 2		Other
ActionNova Biomedical Issued on 1/27/2006 an Advisory Notice to Stat Profile CCX Customers to report the malfunction and request the Good Laboratory Practices (GLP) be used and review be made to assure the calibration status and QC is being performed. A new software version is scheduled to be released to correct the error.
Quantity in Commerce408 units
DistributionNationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CHL
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