ClearanceBrief
Recall Z-0497-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Sunquest Information Systems

Reference Library Interface Version 5.3

DateJan 30, 2003 (initiated Dec 6, 2002)
StatusTerminated
ReasonSoftware system defect resulting in incomplete patient results information.
Root causeOther
ActionProduct Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Quantity30
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.