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U.S. Department of Health and Human Services

Class 2 Device Recall Sunquest Laboratory LabAccess Results Workstation

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  Class 2 Device Recall Sunquest Laboratory LabAccess Results Workstation see related information
Date Initiated by Firm October 05, 2010
Date Posted August 24, 2012
Recall Status1 Terminated 3 on August 24, 2012
Recall Number Z-2272-2012
Recall Event ID 62714
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Sunquest Laboratory LabAccess Results Workstation (LARS)
Code Information Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
Recalling Firm/
Manufacturer		 Sunquest Information Systems, Inc.
250 S Williams Blvd
Tucson AZ 85711-4472
For Additional Information Contact
520-570-2252
Manufacturer Reason
for Recall		 The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
FDA Determined
Cause 2		 Software design
Action An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.
Quantity in Commerce 151 sites
Distribution Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
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.
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