ClearanceBrief
Recall Z-0495-03 ยท JQP Calculator/Data Processing Module, For Clinical Use

Misys Healthcare Systems

Misys Laboratory, GUI version 5.3

DateJan 30, 2003 (initiated Dec 20, 2002)
StatusTerminated
ReasonAn incorrect collection date and time may be accepted and filed to the patient file.
Root causeOther
ActionThe firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.
Quantity465
DistributionNationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.