Recalls / —

—#46455

Product

Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834

FDA product code

LOQ — Device, General Purpose, Hematology

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K032000

Affected lot / code info

All software versions.

Why it was recalled

Beckman has confirmed that erroneous results could be reported when the workstation database crashes.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2006-04-17

Posted by FDA

2006-07-18

Terminated

2012-04-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #46455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.