• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON CX(r) systems, ImmunoProtein Calibrator Set

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


New Search Back to Search Results
 Class 2 Recall
SYNCHRON CX(r) systems, ImmunoProtein Calibrator Set
see related information
Date Posted March 20, 2012
Recall Status1 Terminated on April 17, 2012
Recall Number Z-1229-2012
Recall Event ID 61122
Premarket Notification
510(K) Number
K883181 
Product Classification Calibrator, Secondary - Product Code JIT
Product Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is intended for use on SYNCHRON CX Systems for the calibration of IgA, IgG, IgM, and Transferrin (TRF).
Code Information Lot Number: M901330 and higher Other Lot numbers: M706000, M801451, M808220
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact B. Melina Cimler, Ph.D
714-993-8916
Manufacturer Reason
for Recall
A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Beckman Coulter sent an Urgent Field Safety Notice letter dated August 24, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers with questions regarding the product correction action were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-993-8916.
Quantity in Commerce 1,923 units total (1,882 units in US)
Distribution Worldwide Distribution - USA (nationwide) and Canada
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 = JIT and Original Applicant = BECKMAN INSTRUMENTS, INC.
-
-