—#40306

Product

Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Uint) 988610 (LH Connection Unit)

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: NA

Why it was recalled

Risk of injury to workers due to mechanical or electrical hazards.

Root cause (FDA determination)

Other

Action the firm took

Letters were sent advising of the hazard during the week of June 20, 2005 it stated that the units would be upgraded by appointment.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: USA and Canada

Timeline

Recall initiated: 2005-06-20
Posted by FDA: 2005-07-22
Terminated: 2012-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.