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Terminated

Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834

FDA Recall Z-1245-06 · Posted 2006-07-18

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeLOQ
Date Initiated2006-04-17
Date Terminated2012-04-19
Product Quantity759

Reason for Recall

Beckman has confirmed that erroneous results could be reported when the workstation database crashes.

Firm Action

A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032000COULTER LH 500 HEMATOLOGY ANALYZERBeckman Coulter, Inc. · 2003-08-13

Official Source

View FDA Recall →

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

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