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Terminated

Misys Laboratory version 6.1 - Microbiology Module

FDA Recall Z-0088-06 · Posted 2005-10-22

Recall StatusTerminated
Product CodeJQP
Date Initiated2005-09-29
Date Terminated2006-02-10
Product Quantity67

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.

Firm Action

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

Distribution Pattern

Nationwide and Canada, Denmark, Emirates, Saudi Arabia, United Kingdom

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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