RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials W
FDA device recall Z-2110-2010 · posted 2010-07-28 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- 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.
- Action taken
- 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 remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFF
- Quantity affected
- 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.
- Date initiated
- 2010-06-24
- Date posted
- 2010-07-28
- Date terminated
- 2010-09-23
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCHRON(R) HEPARIN RESPONSE TEST (K904003) | Intensive Technology, Inc. | 1990-11-29 |