Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
FDA device recall Z-0678-03 · posted 2003-03-26 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 520
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
- Date initiated
- 2003-01-17
- Date posted
- 2003-03-26
- Date terminated
- 2004-05-07
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.