Z-0934-2008

Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of...

Name: Z-0934-2008 Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of...
Creator: Inotech Biosystems Intl., Inc
Published: 2007-08-20
License: https://open.fda.gov/license/

Inotech Biosystems Intl., Inc / initiated 2007-08-20 / Terminated / root cause: labeling and UDI

FDA source

Inotech Biosystems Intl., Inc began a recall of 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... on 2007-08-20. The reason FDA records is "Erroneous Coagulation Tests". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0934-2008
Status: Terminated
Initiated: 2007-08-20
Posted: 2008-02-07
Terminated: 2012-08-07
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
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Erroneous Coagulation Tests
Root cause tag: labeling and UDI
FDA 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 in commerce: 37,370 tubes
Distribution: Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada.
Product codes and lots: Lots #: 120706 and 300407

Product code JPA

K870771Class IIPt Heparin AdsorbentProbe-Tek, Inc. / cleared 1987-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)