Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adso
FDA device recall Z-0934-2008 · posted 2008-02-07 · Terminated
Recall details
- Recalling firm
- Inotech Biosystems Intl., Inc
- Reason for recall
- Erroneous Coagulation Tests
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 37,370 tubes
- Distribution
- Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada.
- Date initiated
- 2007-08-20
- Date posted
- 2008-02-07
- Date terminated
- 2012-08-07
- Location
- Rockville, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PT HEPARIN ADSORBENT (K870771) | Probe-Tek, Inc. | 1987-04-23 |