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U.S. Department of Health and Human Services

Class 2 Device Recall IMMAGE Immunochemistry Systems

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  Class 2 Device Recall IMMAGE Immunochemistry Systems see related information
Date Initiated by Firm August 24, 2010
Date Posted April 20, 2011
Recall Status1 Terminated 3 on June 26, 2012
Recall Number Z-2045-2011
Recall Event ID 57750
510(K)Number K962294  
Product Classification Reagent, general purpose - Product Code LDT
Product IMMAGE¿ Immunochemistry Systems Wash Solution Part Number: 447060

The IMMAGE¿ Immunochemistry Systems Wash Solution is intended for use with IMMAGE¿ Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE¿ Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
Code Information Lot Numbers: 71744 
Recalling Firm/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. O'Donovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed an Immage¿ Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However, this lot was inadvertently shipped to the U.S. and delivered to five customers.
FDA Determined
Cause 2
Action The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage¿ Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967; package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products. If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.
Quantity in Commerce 9 units total in US
Distribution Nationwide distribution: USA including states of : AL, CA, MI and IN.

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 = LDT and Original Applicant = BECKMAN INSTRUMENTS, INC.