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Terminated

Coulter AcT 5diff Autoloader (AL) Hematology Analyzer

FDA Recall Z-0987-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-04-20
Date Terminated2005-09-02
Product Quantity70

Reason for Recall

Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.

Firm Action

Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030291COULTER ACT 5DIFF AUTOLOADER (AL)Beckman Coulter, Inc. · 2003-04-17

Official Source

View FDA Recall →

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

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