This page has been archived on the Web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.
LifeCodes PF4 Enhanced
- Starting date:
- July 27, 2012
- Posting date:
- September 3, 2012
- 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-23821
Recalled Products
A. LifeCodes PF4 Enhanced
Reason
Anomalous decreases in the average Optical Density (OD) results. This reduction in average OD causes the positive control values to be too low for a valid assay.
Affected products
A. LifeCodes PF4 Enhanced
Lot or serial number
092711-X45
Model or catalog number
X-HAT45
Companies
- Manufacturer
-
Gen-Probe GTI Diagnostics Inc. DBA
Gen-Probe Incorporated