UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 Analyzer is a quantitative, aut

FDA device recall Z-2145-2011 · posted 2011-05-05 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

566 units

Distribution

Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines

Date initiated

2011-02-11

Date posted

2011-05-05

Date terminated

2014-09-02

Location

Brea, CA

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