This page has been archived on the Web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.
Pk Cmv-Pa Control Set
- Starting date:
- August 1, 2017
- Posting date:
- September 5, 2017
- 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-64394
Reason
PK CMV-PA reactive and non-reactive control vials from affected lots may contain lint. Presence of lint in the control tubes has the potential to interfere with photometry and the controls may not test as expected and necessitate the run be repeated. Donor results are not impacted by this issue.
Affected products
Pk Cmv-Pa Control Set
Lot or serial number
309048
309069
Model or catalog number
PA2302
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES