Recall Z-2110-2010 ยท KFF Assay, Heparin
International Technidyne Corp.
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
| Date | Jul 28, 2010 (initiated Jun 24, 2010) |
| Status | Terminated |
| Reason | An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures. |
| Root cause | Other |
| Action | ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have |
| Quantity | 38 in US, 3 Out of US |
| Distribution | Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST Intensive Technology, Inc., Nov 29, 1990 |