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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 Laboratorysee related information
Date Initiated by FirmSeptember 25, 2003
Date PostedDecember 18, 2003
Recall Status1 Terminated 3 on September 03, 2004
Recall NumberZ-0235-04
Recall Event ID 27575
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductCalculator/ 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 ContactDavid 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
ActionFirm has issued notifcation to all affected customers.
Quantity in Commerce485
DistributionUS, UK, Ireland, Denmark, Canada, Bermuda, Saudi Arabia and United Arab Emirates
Total Product Life CycleTPLC 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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