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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 22, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on June 25, 2004
Recall Number Z-1217-03
Recall Event ID 27029
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
Code Information Version 5.2 through 5.3.2 using LabAccess Results
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Barbara Brown
520-733-6403
Manufacturer Reason
for Recall		 Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
FDA Determined
Cause 2		 Other
Action Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.
Quantity in Commerce 171
Distribution Nationwide and to United Kingdom, Canada, Denmark, Ireland, Saudi Arabia, United Arab Emirates.
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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