ClearanceBrief
Recall Z-0974-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3

DateJul 2, 2003 (initiated Jun 2, 2003)
StatusTerminated
ReasonSusceptibility comments are ommited from Microbiology cumulative reports
Root causeOther
ActionThe recall notification, Product Safety Notice PSN-03-L26 dated June 2, 2003 was sent by fax.
Quantity471
DistributionNationwide and to Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates, United Kingdom,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.