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
|
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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.
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510(K) Database |
510(K)s with Product Code = JPA and Original Applicant = PROBE-TEK, INC.
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