This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ITC Hemochron JR APTT Test Cuvette (2014-06-24)
- Starting date:
- June 24, 2014
- Posting date:
- July 7, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40391
Recalled Products
ITC Hemochron JR APTT Test Cuvette
Reason
Results from activated partial thromboplastin time cuvettes (J103), lot A4JCA001, may be erroneously elevated or report an error code, out-of-range high (OOR-H). These observations can occur with either a non-heparinized or heparinized specimen.
Affected products
ITC Hemochron JR APTT Test Cuvette
Lot or serial number
A4JCA001
Model or catalog number
J103
Companies
- Manufacturer
-
International Technidyne Corp.
8 Olsen Avenue
Edison
08820
New Jersey
UNITED STATES