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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 January 27, 2012
Date Posted October 01, 2012
Recall Status1 Terminated 3 on May 30, 2013
Recall Number Z-0003-2013
Recall Event ID 63152
510(K)Number K963048  
Product Classification System, test, rheumatoid factor - Product Code DHR
Product IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070

The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Code Information Lot# M012376 and M101865 
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated January 27, 2012 with an attached PCA Response Form to all customers who purchased the IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use of IMMAGE RF reagent lots M012376 and M101865; call Order Assistance at (800) 526-3821 in the United States, (800) 463-7828 in Canada or contact your local Beckman Coulter representative for replacements; and complete and return the enclosed FAX BACK RESPONSE FORM within 10 days via mail at: Beckman Coulter, Inc., 250 S. Kraemer Blvd, Mail Stop A2.0246, Brea, CA 92822-8000; Attn: Regulatory Affairs or fax to: (714) 961-4234. Note: Beckman Coulter has added additional release testing that will assure future lots RF will meet the reference interval claim of the IMMAGE RF Instructions for Use (IFU). If you have any questions concerning this letter, contact Beckman Coulter Support Center (call Center) on the Beckman Coulter Website at: http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 925 units
Distribution Worldwide distribution: USA (nationwide) and country of: 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 = DHR and Original Applicant = BECKMAN INSTRUMENTS, INC.