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 Beckman Coulter

  • 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 Beckman Coulter see related information
Date Initiated by Firm October 10, 2003
Date Posted November 19, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0136-04
Recall Event ID 27512
Product Classification Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
Product Coulter DNA Prep Reagents Kit Part 6607055
Code Information Lot # 760203k-760208k, 760213k, 760218k
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Kathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		 Labeling Error-Omission of 'Research Use Only'
FDA Determined
Cause 2		 Other
Action All customers are to be notified with a product correction action letter.
Quantity in Commerce 284
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.
-
-