Recall Z-0934-2008 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
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
| Date | Feb 7, 2008 (initiated Aug 20, 2007) |
| Status | Terminated |
| 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 m |
| Quantity | 37,370 tubes |
| Distribution | Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870771 | PT HEPARIN ADSORBENT Probe-Tek, Inc., Apr 23, 1987 |