Inotech Biosystems Intl., Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Inotech Biosystems Intl., Inc
Lot Codes / Batch Numbers
Lots #: 120706 and 300407
Products Sold
Lots #: 120706 and 300407
Inotech Biosystems Intl., Inc is recalling Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing due to Erroneous Coagulation Tests. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Erroneous Coagulation Tests
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026