ClearanceBrief
Recall Z-0791-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System versions 5.23 and 5.3

DateMay 8, 2003 (initiated Mar 26, 2003)
StatusTerminated
ReasonWith SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.
Root causeOther
ActionThe firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13.
Quantity463
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.