—#43740

Product

COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

FDA product code: GKJ — Spinner, Slide, Automated
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K962988
Affected lot / code info: PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R 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 #43740. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.