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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel Dxl 800 Access Immunoassay System

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 Class 2 Recall
UniCel Dxl 800 Access Immunoassay System
see related information
Date Posted November 19, 2012
Recall Status1 Terminated on November 19, 2012
Recall Number Z-0345-2013
Recall Event ID 63505
Premarket Notification
510(K) Number
K023764 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Code Information Serial Numbers: 600000 through 602389
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
FDA Determined
Cause 2
DESIGN: Process Design
Action Beckman Coulter sent a field modification was released in August 2011 which included: - Installing a new aspirate and dispense tubing routing bracket. - Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing. During installation the FSE informed the customer: -That aspirate and dispense tubing are different lengths. - That probes are not interchangeable with other instruments once tubing has been modified. - To route probe tubing by referring to the labels on the tubing. An updated service document, Routine Maintenance Changes, A82294B was provided to every customer. For questions regarding this recall call 714-961-4483.
Quantity in Commerce 1,756 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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