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 Inotech brand Heparin Adsorbant

  • 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 Inotech brand Heparin Adsorbant see related information
Date Initiated by Firm August 20, 2007
Date Posted February 07, 2008
Recall Status1 Terminated 3 on August 07, 2012
Recall Number Z-0934-2008
Recall Event ID 45407
510(K)Number K870771  
Product Classification Heparin Adsorbant - Product Code JPA
Product Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems International, Inc., Rockville, MD 20855
Code Information Lots #: 120706 and 300407
Recalling Firm/
Manufacturer		 Inotech Biosystems Intl., Inc
15713 Crabbs Branch Way Ste 110
Rockville MD 20855-2607
For Additional Information Contact David Mines
301-670-2850
Manufacturer Reason
for Recall		 Erroneous Coagulation Tests
FDA Determined
Cause 2		 Labeling design
Action The recalling firm notified consignees by phone on 08/20/07 and provided instructions for increasing the speed of centrifugation from 1,500 x g to 2,500 x g and decanting the supernatant aliquot carefully so as to not draw in resin fibers that may be stuck on the test tube walls during sample preparation for testing in the coagulation studies. The firm updated their recall notification on 10/01/07 as an Urgent Recall/Correction to alert healthcare practitioners to not use "lupus sensitive reagents" with the heparin absorbant product and that Platelet Factor 3 and any other negatively charged molecule in the plasma may interact with the resin causing false high readings due to the partial removal of the clotting initiating factors.
Quantity in Commerce 37,370 tubes
Distribution Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to 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 = JPA and Original Applicant = PROBE-TEK, INC.
-
-