—#90993

Product

Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: Serial Numbers: AN07020, AN05001, AN05004, AM44041, AN07015, AM51052, AN10031

Why it was recalled

The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.

Root cause (FDA determination)

Other

Action the firm took

Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States 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: Nationwide to: AZ, LA, IL, NY, PA & TN

Timeline

Recall initiated: 2009-07-28
Posted by FDA: 2010-06-25
Terminated: 2012-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.