Date Initiated by Firm |
January 17, 2003 |
Date Posted |
March 26, 2003 |
Recall Status1 |
Terminated 3 on May 07, 2004 |
Recall Number |
Z-0678-03 |
Recall Event ID |
25499 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Misys Laboratory,
Calculator/Data processing Module for Clinical Use (21 CFR 862.2100)
Misys Laboratory GUI Version 5.3 |
Code Information |
Version 5.3 |
Recalling Firm/ Manufacturer |
Misys Healthcare Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact |
Cheryl Terpning 520-382-6218
|
Manufacturer Reason for Recall |
Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
|
FDA Determined Cause 2 |
Other |
Action |
Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready. |
Quantity in Commerce |
520 |
Distribution |
Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates. |
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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