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Terminated

Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter

FDA Recall Z-0571-03 · Posted 2003-02-25

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2002-12-10
Date Terminated2004-04-21
Product Quantity447

Reason for Recall

Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.

Firm Action

Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011342COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632Beckman Coulter, Inc. · 2001-07-09K962988COULTER GEN-S SYSTEMCoulter Corp. · 1996-10-30

Official Source

View FDA Recall →

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

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