ClearanceBrief
Recall Z-0235-04 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Calculator/ Data Processing Module for Clinical Use.

DateDec 18, 2003 (initiated Sep 25, 2003)
StatusTerminated
ReasonSoftware Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
Root causeOther
ActionFirm has issued notifcation to all affected customers.
Quantity485
DistributionUS, UK, Ireland, Denmark, Canada, Bermuda, Saudi Arabia and United Arab Emirates
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.