Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Unicel DxH 800 Coulter Cellular Analysis System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Unicel DxH 800 Coulter Cellular Analysis Systemsee related information
Date Initiated by FirmFebruary 12, 2010
Date PostedSeptember 01, 2010
Recall Status1 Terminated 3 on September 10, 2010
Recall NumberZ-2338-2010
Recall Event ID 55699
510(K)NumberK081930 
Product Classification Counter, Differential Cell - Product Code GKZ
ProductUnicel DxH 800 Coulter Cellular Analysis System
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactClair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu
FDA Determined
Cause 2		Software design
ActionThe customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.
Quantity in Commerce53 units in USA and 3 units in Canada
DistributionThroughout the United States and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GKZ
-
-