Devices

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

Model / Serial
Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
Product Description
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.
Manufacturer
International Technidyne Corp.
1 Event
- Recall of Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

Manufacturer

International Technidyne Corp.

Manufacturer Address
International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA

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