Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IMMAGE IMMUNOCHEMISTRY SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall IMMAGE IMMUNOCHEMISTRY SYSTEM see related information
Date Initiated by Firm May 21, 2010
Date Posted August 10, 2010
Recall Status1 Terminated 3 on May 22, 2012
Recall Number Z-2195-2010
Recall Event ID 55787
510(K)Number K962294  
Product Classification nephelometer - 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 CA 92821-6208
For Additional Information Contact
714-993-5321
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		 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 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 = JQX and Original Applicant = BECKMAN INSTRUMENTS, INC.
-
-