Recalls / —

—#25863

Product

Coulter LH 700 Series Hematology Analyzers

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K011342

Affected lot / code info

All lots.

Why it was recalled

Biohazard situation exists for users.

Root cause (FDA determination)

Other

Action the firm took

Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

Nationwide and Canada.

Timeline

Recall initiated

2003-01-10

Posted by FDA

2003-02-05

Terminated

2003-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.