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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems

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 Class 2 Device Recall UniCel DxC 880i, 860i, 680i, and 660i Integrated Systemssee related information
Date Initiated by FirmAugust 01, 2011
Date PostedNovember 19, 2012
Recall Status1 Terminated 3 on November 19, 2012
Recall NumberZ-0347-2013
Recall Event ID 63505
510(K)NumberK042291 
Product Classification Electrode, ion specific, potassium - Product Code CEM
ProductUniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. 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: Included in the corresponding Dxl system.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactClair 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		Process design
ActionBeckman 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.
DistributionWorldwide 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 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 = CEM
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