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.
FDA Recall Z-2110-2010 · Posted 2010-07-28
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Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeKFF
Date Initiated2010-06-24
Date Terminated2010-09-23
Product Quantity38 in US, 3 Out of US
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.
Firm 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 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 [email protected].
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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