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
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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
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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 |
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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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