UniCel DxH 800 Coulter Cellular Analysis System 의 리콜

Recall

58282

Class 2

Z-2114-2011

2010-10-20

2011-04-29

Terminated

United States

2014-09-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98884

For panels containing cbc: the rbc and hct are improperly corrected and not flagged when there is a wbc pump failure and the wbc ~ 140x103/ul. for body fluid panels: the rbc is improperly corrected and not flagged when there is a wbc pump failure. impact: erroneous rbc and/or hct could affect the interpretation and management of patients at risk with various types of anemias.

The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue. When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.