Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne
FDA device recall Z-1093-2011 · posted 2011-02-11 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
- Action taken
- ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail techsupport@itcmed.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KQG
- Quantity affected
- 265 boxes (95 ACT Tubes per box)
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-11-30
- Date posted
- 2011-02-11
- Date terminated
- 2012-08-22
- Location
- Edison, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCHRON RESPONSE (K983475) | International Technidyne Corp. | 1999-05-03 |