Recalls / —

—#43728

Product

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

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K011342

Affected lot / code info

PN 6605632 and 6605632R All Software Versions

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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)

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2005-12-15

Posted by FDA

2006-02-04

Terminated

2012-01-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.