Device Recall UniCel DxH 600 Coulter Cellular Analysis System 의 리콜

Recall

67058

Class 2

Z-1829-2014

2013-11-08

2014-06-20

Terminated

United States

2014-12-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124630

Beckman coulter is recalling the unicel dxh800 and unicel dxh600 coulter analysis systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nrbc), automated white blood cell differential and the reticulocyte.

An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the 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 Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative. Beckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.