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
|