FDA Medical Device Recalls (openFDA)
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 number
- Z-0934-2008
- Recalling firm
- Inotech Biosystems Intl., Inc
- 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
- Status
- Terminated
- Initiated
- 2007-08-20
- Posted
- 2008-02-07
- Terminated
- 2012-08-07
- Reason
- Erroneous Coagulation Tests
- Root cause
- 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
- 37,370 tubes
- Distribution
- Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada.
- Lot, serial or model codes
- Lots #: 120706 and 300407
- 510(k) numbers
- K870771
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1832416
- Firm city
- Rockville
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06