—#91625

Product

COULTER LH 500 Series System

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K032000
Affected lot / code info: All serial Numbers.

Why it was recalled

The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu

Root cause (FDA determination)

Software design

Action the firm took

The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Throughout the United States and Canada

Timeline

Recall initiated: 2010-02-12
Posted by FDA: 2010-09-01
Terminated: 2010-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91625. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.