COULTER LH 700 Series Hematology Analyzers
FDA Recall Z-0418-03 · Posted 2003-01-09
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2002-11-08
Date Terminated2003-07-17
Product Quantity132
Reason for Recall
Software.
Firm Action
Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
Root Cause
Other
Distribution Pattern
Nationwide and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.