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

FDA device recall Z-2148-2011 · 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 NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.

Action taken

Beckman Coulter sent an Urgent Product Correction letter, dated February 11, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were informed the 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 their laboratory staff and retain this notification as part of their 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

Worldwide Distribution - USA including AL, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austr

Date initiated

2011-02-11

Date posted

2011-05-05

Date terminated

2014-09-02

Location

Brea, CA

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