Z-2110-2010

RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes...

Name: Z-2110-2010 RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes...
Creator: International Technidyne Corp.
Published: 2010-06-24
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2010-06-24 / Terminated

FDA source

International Technidyne Corp. began a recall of 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... on 2010-06-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2110-2010
Status: Terminated
Initiated: 2010-06-24
Posted: 2010-07-28
Terminated: 2010-09-23
Recalling firm: Accriva Diagnostics, Inc.
Product: 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.
Product code: KFF Assay, Heparin
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.
FDA 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 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].
Quantity in commerce: 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.
Product codes and lots: Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016

Product code KFF

K904003Class IIHemochron(r) Heparin Response TestIntensive Technology, Inc. / cleared 1990-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)