COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R
FDA Recall Z-0474-06 · Posted 2006-02-04
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2005-12-15
Date Terminated2012-01-26
Product Quantity1715
Reason for Recall
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
Firm Action
A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
Root Cause
Other
Distribution Pattern
Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.