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 3 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 3 Device Recallsee related information
Date Initiated by FirmFebruary 10, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 02, 2004
Recall NumberZ-1099-04
Recall Event ID 29098
510(K)NumberK014103 
Product Classification System, Test, Low Density, Lipoprotein - Product Code MRR
ProductLDL Cholesterol Reagent (LDLD) Part No. 969706
Code Information Lot M210044
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
FDA Determined
Cause 2		Other
Quantity in Commerce291
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MRR
-
-