| Class 2 Device Recall Mysis Laboratory |  |
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 |
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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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