FDA Device

COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R

Hazard

There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

What You Should Do

Remedy

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)

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Products

COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R
Brand
Beckman Coulter Inc
UPC
PN 6605632 and 6605632R All Software Versions

Units Affected

1715

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