ClearanceBrief
Recall Z-0647-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Sunquest Information Systems

Misys Laboratory, version 5.3 with Reference Laboratory Interface

DateMar 13, 2003 (initiated Oct 18, 2002)
StatusTerminated
ReasonSoftware anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
Root causeOther
ActionA product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Quantity2
DistributionStates of WI, and IL.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.