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

  • 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 see related information
Date Initiated by Firm June 11, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 10, 2004
Recall Number Z-0935-04
Recall Event ID 28909
510(K)Number K955644  
Product Classification Enzyme Immunoassay, Carbamazepine - Product Code KLT
Product Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Code Information Lot M207140
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		 Product was found to produce higher recoveries by about 7-12% compared to other lots.
FDA Determined
Cause 2		 Other
Action Users were requested to discard and ask for replacement of the lot in question by letter.
Quantity in Commerce unknown
Distribution Nationwide and Canada
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 = KLT and Original Applicant = BECKMAN INSTRUMENTS, INC.
-
-