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U.S. Department of Health and Human Services

Class 2 Device Recall IGFBP3 ELISA Reagent Kit

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 Class 2 Recall
IGFBP3 ELISA Reagent Kit
see related information
Date Posted May 11, 2011
Recall Status1 Terminated on December 02, 2011
Recall Number Z-2184-2011
Recall Event ID 58583
Premarket Notification
510(K) Number
K951707 
Product Classification Radioimmunoassay, Human Growth Hormone - Product Code CFL
Product IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.
Code Information Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Manufacturer Reason
for Recall
The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Beckman Coulter sent a Product Corrective Action (PCA) letter with attached customer response form on March 30, 2011 to all customers who have the affected product, IGFBP- 3 Enzyme-Linked immunosorbent Assay ( ELISA) kit .This kit provides materials for the quantitative measurement of IGFBP-3 in serum. The letter informed the customers of the reason for recall, the products affected and actions to be taken. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they were asked to provide a copy of the letter to them. Beckman further asked consignees to complete and return the enclosed Response Form within 10 days so they are assured consignees have received this important communication. Questions were directed to the Beckman Coulter Customer Support Center. - Website: http://www.beckmancoulter.com/customersupport/support - Phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada contact local Beckman Coulter representative.
Quantity in Commerce 1,212 units
Distribution Worldwide -- USA, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Italy, Korea, Republic of, Lebanon, Luxembourg, Morocco, Netherlands, New Zealand, Puerto Rico, Syrian Arab Republic, Taiwan, Thailand, Turkey & United Kingdom
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 = CFL and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.
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