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Terminated

Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

FDA Recall Z-1377-05 · Posted 2005-08-17

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2005-07-06
Date Terminated2012-04-26
Product Quantity36

Reason for Recall

Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.

Firm Action

Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.

Root Cause

Other

Distribution Pattern

USA

Official Source

View FDA Recall →

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

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