Device Recall UniCel CxH800 Coulter Cellular Analysis System 의 리콜

Recall

58305

Class 2

Z-2145-2011

2011-02-11

2011-05-05

Terminated

United States

2014-09-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98954

The recall was initiated because the dxh 800 may fail to meet the carryover specification for the wbc differential (diff) when the wbc is greater than 70 x 10 to the 3rd power cells/micro l (70 x 10 to the 9th power cells/l). beckman coulter indicated the diff% carryover is unlikely to have clinical impact.

Beckman Coulter sent a Product Corrective Action (PCA) letter with attached Recall Response Form via US Postal Service on February 11, 2011, to all customers who have the affected instruments. Consignees were informed of the reasons for recall, the products affected and that a resolution for these issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, Consignees were told to contact Beckman Coulter, Customer Service at (800) 526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.