ClearanceBrief
Recall Z-0626-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System versions 5.2, 5.23 and 5.3

DateMar 6, 2003 (initiated Jan 31, 2003)
StatusTerminated
ReasonSoftware anomaly. Patient results may be filed in the incorrect patient file
Root causeOther
ActionNotice of the correction was made by Fax on 1/31/2003. The notice indicated a procedural workaround to prevent the occurance of the defect. Corrections will be made to the software at only affected sites. These have been instructed to contact Applications Interface to schedule correction of the interface.
Quantity542
DistributionNationwide and to United Kingdom, Ireland, Belgium, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.