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U.S. Department of Health and Human Services

Class 2 Device Recall IMMAGE IMMUNOCHEMISTRY SYSTEM

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 Class 2 Recall
IMMAGE IMMUNOCHEMISTRY SYSTEM
see related information
Date Posted August 10, 2010
Recall Status1 Terminated on May 22, 2012
Recall Number Z-2195-2010
Recall Event ID 55787
Premarket Notification
510(K) Number
K962294 
Product Classification Nephelometer, For Clinical Use - Product Code JQX
Product IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
Code Information Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.
Quantity in Commerce 1309
Distribution Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and 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 = JQX and Original Applicant = BECKMAN INSTRUMENTS, INC.
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