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U.S. Department of Health and Human Services

Class 2 Device Recall Mysis Laboratory

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  Class 2 Device Recall Mysis Laboratory see related information
Date Initiated by Firm September 25, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on September 03, 2004
Recall Number Z-0235-04
Recall Event ID 27575
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Calculator/ Data Processing Module for Clinical Use.
Code Information Verisons 5.2, 5.23 and 5.3
Recalling Firm/
Manufacturer
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711-3609
For Additional Information Contact David Cox
520-733-6403
Manufacturer Reason
for Recall
Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
FDA Determined
Cause 2
Other
Action Firm has issued notifcation to all affected customers.
Quantity in Commerce 485
Distribution US, UK, Ireland, Denmark, Canada, Bermuda, Saudi Arabia and 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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