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 Recallsee related information
Date Initiated by FirmOctober 31, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 17, 2004
Recall NumberZ-0163-04
Recall Event ID 27678
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
ProductICON 25 hCG Test Kit
Code Information Lot hCG030303
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		False negative urine results are being observed at an increasing rate.
FDA Determined
Cause 2		Other
ActionFirm sent letter to customers on 31 OCT 03 expressing not to use kits and that another lot will be substituted. Destruction of recalled lot is requested.
Quantity in Commerce9040 kits
DistributionNationwide and Canada (limited).
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.
-
-