Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
This recall has been terminated (originally issued March 26, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- January 17, 2003
- Posted
- March 26, 2003
- Terminated
- May 7, 2004
- Recall Number
- Z-0678-03
- Quantity
- 520
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
Distribution
Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
Lot / Code Info
Version 5.3
Root Cause
Other
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.
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