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Terminated

Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265

FDA Recall Z-0637-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKL
Date Initiated2004-02-13
Date Terminated2012-05-08
Product Quantity390

Reason for Recall

Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

Firm Action

Firm sent modified operating instructions to users on 13 February 2004.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

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

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