ClearanceBrief
Recall Z-0867-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System versions 5.2, 5.23, 5.3, 5.3.1 and 5.3.2.

DateMay 29, 2003 (initiated Apr 14, 2003)
StatusTerminated
ReasonIncorrect results could be filed.
Root causeOther
ActionThe firm sent Product Safety Notice PSN-03-L18 by fax to customers on 4/14/2003.
Quantity193
DistributionNationwide and to Ireland, Canada, Denmark, United Kingdom, 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.