ClearanceBrief
Recall Z-0926-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System, version 5.3

DateJun 17, 2003 (initiated May 13, 2003)
StatusTerminated
ReasonTwo clients reported Quality Assurance dates could not be entered after 5/19/03.
Root causeOther
ActionProduct Safety Notice number PSN-03-L24 was issued on May 13, 2003 to all affected customers. It contained an effective workaround and communicated that the software fix was available and also included that for those clients that wanted to install it. Clients are reminded to return acknowledgement cards included in the mailing.
Quantity466
DistributionNationwide, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Kingdom, United Arab Emirates,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.