Device Recall Unicel DxH 800 Coulter Cellular Analysis System 의 리콜

Recall

58705

Class 2

Z-3125-2011

2011-05-09

2011-09-01

Terminated

United States

2012-06-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100102

The recall was initiated because beckman coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the sample aspiration module (sam) during routine use of single-tube presentation station. when the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. the misal.

Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to another laboratory, customers were instructed to provide a copy of the letter to that party. Customers were also asked to complete and return the enclosed Response Form within ten (10) days, so Beckman can be assured they have received this important communication. Questions concerning this notice, were directed to the Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.