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Terminated

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645

FDA Recall Z-0669-03 · Posted 2003-03-21

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2002-12-27
Date Terminated2003-07-26
Product Quantity234

Reason for Recall

Incorrect Hemoglobin result can be reported with software version 2A and higher.

Firm Action

Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.

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. · 2001-07-09

Official Source

View FDA Recall →

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

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