Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Misys Laboratory

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Misys Laboratory see related information
Date Initiated by Firm October 18, 2002
Date Posted March 13, 2003
Recall Status1 Terminated 3 on December 03, 2004
Recall Number Z-0647-03
Recall Event ID 25009
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory, version 5.3 with Reference Laboratory Interface
Code Information Version 5.3 with Reference Laboratory Interface
Recalling Firm/
Manufacturer		 Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark S. Ellis
520-382-6219
Manufacturer Reason
for Recall		 Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
FDA Determined
Cause 2		 Other
Action A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Quantity in Commerce 2
Distribution States of WI, and IL.
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.
-
-