COULTER DxH Diluent 의 리콜

Recall

71045

Class 2

Z-1616-2015

2015-04-13

2015-05-15

Terminated

United States

2015-10-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135907

Beckman coulter has received an increased number of complaints related to hemoglobin (hgb) on unicel dxh 800 and dxh 600 coulter cellular analysis systems. the use of the dxh diluent lots listed in the recall notice may eventually result in a compromised hgb chamber.

An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.