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U.S. Department of Health and Human Services

Class 2 Device Recall IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent

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  Class 2 Device Recall IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent see related information
Date Initiated by Firm May 31, 2011
Date Posted July 27, 2011
Recall Status1 Terminated 3 on June 03, 2013
Recall Number Z-2887-2011
Recall Event ID 59016
510(K)Number K963048  
Product Classification System, test, rheumatoid factor - Product Code DHR
Product IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529.

Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.
Code Information Lot Number: M908398 & M911529
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92822-6232
Manufacturer Reason
for Recall		 The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.
FDA Determined
Cause 2		 Pending
Action Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE/PRODUCT CORRECTION" letter dated May 31, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products. Customers were asked to complete and return an attached FAX BACK Response Form to 714-961-4234. Replacement products may be obtained by calling Order Assistance at 800-526-3821 in the United States, (800) 463-7828 in Canada or contacting your local Beckman Coulter representative. For any questions regarding this notice, contact the Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the United States and Canada; or contact your local sales representative.
Quantity in Commerce 6302 units (850 in the US)
Distribution Worldwide Distribution--USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Macao, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
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 = DHR and Original Applicant = BECKMAN INSTRUMENTS, INC.
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