Atlas FDA

Misys Laboratory version 6.1 - Microbiology Module

FDA device recall Z-0088-06 · posted 2005-10-22 · Terminated

Recall details

Recalling firm
Misys Healthcare Systems
Reason for recall
Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
Action taken
Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product.
Root cause
Other
Status
Terminated
Product code
JQP
Quantity affected
67
Distribution
Nationwide and Canada, Denmark, Emirates, Saudi Arabia, United Kingdom
Date initiated
2005-09-29
Date posted
2005-10-22
Date terminated
2006-02-10
Location
Tucson, AZ

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