ClearanceBrief
Recall Z-0670-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System Version 5.3

DateMar 21, 2003 (initiated Feb 19, 2003)
StatusTerminated
ReasonSoftware anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry
Root causeOther
ActionNotification was made by FAX to customers. A procedureal work around was provided also. The firm will announce the availability of a software fix in the future.
Quantity464
DistributionNationwide and to United Kingdom, Ireland, 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.