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U.S. Department of Health and Human Services

Class 2 Device Recall Electronic Data Interchange

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  Class 2 Device Recall Electronic Data Interchange see related information
Date Initiated by Firm September 29, 2009
Date Posted February 26, 2010
Recall Status1 Terminated 3 on July 01, 2010
Recall Number Z-0865-2010
Recall Event ID 53483
510(K)Number K001387  
Product Classification Calculator/data processing module for clinical use - Product Code JQP
Product i-STAT HL7 Interface

The HL7 Interface product is an accessory to the analyzer
Code Information i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter J. Scott
609-454-9270
Manufacturer Reason
for Recall		 Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.
FDA Determined
Cause 2		 Software design
Action Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.
Quantity in Commerce 36
Distribution Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
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 = JQP and Original Applicant = I-STAT CORP.
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