Unicel DxH 800 Coulter Cellular Analysis System
FDA Recall Z-2338-2010 · Posted 2010-09-01
Advertisement
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-02-12
Date Terminated2010-09-10
Product Quantity53 units in USA and 3 units in Canada
Reason for Recall
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
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Throughout the United States and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement