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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON CX(r) systems, ImmunoProtein Calibrator Set

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  Class 2 Device Recall SYNCHRON CX(r) systems, ImmunoProtein Calibrator Set see related information
Date Initiated by Firm August 26, 2009
Date Posted March 20, 2012
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-1229-2012
Recall Event ID 61122
510(K)Number K883181  
Product Classification Calibrator, multi-analyte mixture - Product Code JIT
Product Synchron CX Immuno-Protein Cal, part number: 442840,

other product code: CKA

The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is intended for use on SYNCHRON CX Systems for the calibration of IgA, IgG, IgM, and Transferrin (TRF).
Code Information Lot Number: M901330 and higher  Other Lot numbers: M706000, M801451, M808220 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact B. Melina Cimler, Ph.D
714-993-8916
Manufacturer Reason
for Recall		 A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter sent an Urgent Field Safety Notice letter dated August 24, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers with questions regarding the product correction action were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-993-8916.
Quantity in Commerce 1,923 units total (1,882 units in US)
Distribution Worldwide Distribution - USA (nationwide) 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 = JIT and Original Applicant = BECKMAN INSTRUMENTS, INC.
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