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U.S. Department of Health and Human Services

Class 2 Device Recall Access Peristaltic Pump

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  Class 2 Device Recall Access Peristaltic Pump see related information
Date Initiated by Firm October 09, 2008
Date Posted March 02, 2010
Recall Status1 Terminated 3 on May 04, 2012
Recall Number Z-0914-2010
Recall Event ID 50703
510(K)Number K023764  K060256  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.

Intended to be used with the Access Immunoassay System to remove waste from the system.
Code Information Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab
FDA Determined
Cause 2		 Other
Action Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.
Quantity in Commerce 107 (US), 7 (OUS)
Distribution Worldwide Distribution -- United States and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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