RecallDepth

Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

This recall has been terminated (originally issued August 17, 2005).

Company
Beckman Coulter Inc.
Recall Initiated
July 6, 2005
Posted
August 17, 2005
Terminated
April 26, 2012
Recall Number
Z-1377-05
Quantity
36
Firm Location
Brea, CA
Official Source
View on FDA website ↗

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.

Distribution

USA

Lot / Code Info

Versions 1.1 and 2.0

Root Cause

Other

Action Taken

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

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