This page has been archived on the Web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.
Versant HCV Genotype 2.0 Kit (LIPA) (2014-07-09)
- Starting date:
- July 9, 2014
- Posting date:
- July 22, 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-40599
Recalled Products
Versant HCV Genotype 2.0 Kit (LIPA)
Reason
Siemens Healthcare Diagnostics has become aware of a problem with the substrate component. The vial containing the substrate is defective and the cap does not fit securely, allowing substrate reagent to leak out of the vial if it is not stored upright at all times. The leakage could present itself as an empty or under filled substrate reagent. No evidence shows that this problem will impact the quality of any test results produced from this reagent. This issue has been investigated and confirmed by them manufacturer.
Affected products
Versant HCV Genotype 2.0 Kit (LIPA)
Lot or serial number
- 238273
- 240475
Model or catalog number
06719382
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES