This page has been archived on the Web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.
Coat-a-Count Direct Androsrenedione Kit (2014-06-12)
- Starting date:
- June 12, 2014
- Posting date:
- June 24, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40187
Recalled Products
- Coat-a-Count Direct Androsrenedione Kit
Reason
Manufacturer has received complaints regarding the coat-a-count direct Androstenedione assay demonstrating a higher frequency of results >10 ng/ml (>25 nmol/l) compared to alternate platforms.
Affected products
A. Coat-a-Count Direct Androsrenedione Kit
Lot or serial number
- 587
- 589
- 591
- 592
- 593
- 596
- 598
- 599
- 601
Model or catalog number
- TKAN1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
5210 Pacific Concourse Drive
Los Angeles
90045
California
UNITED STATES