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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