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Terminated

Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

FDA Recall Z-0039-04 · Posted 2003-10-15

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2003-09-08
Date Terminated2004-03-30
Product Quantity36

Reason for Recall

Samples with high fat content will not count platelets accurately.

Firm Action

Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.

Root Cause

Other

Distribution Pattern

United States and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992511ABX PENTRA 60 HEMATOLOGY ANALYZERAbx Diagnostics · 1999-10-15

Official Source

View FDA Recall →

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

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