This page has been archived on the Web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.
COULTER BODY FLUID CONTROL KIT, LEVEL 1 (2015-06-01)
- Starting date:
- June 1, 2015
- Posting date:
- July 7, 2015
- 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-54014
Recalled Product
A. COULTER BODY FLUID CONTROL KIT, LEVEL 1
Reason
Beckman Coulter has confirmed high and/or out-of-range values for total nucleated cells (TNC) on control level 1... When compared to the published table of expected results. The issue was initially reported in April 2015 by a united states customer. There has been no report of death or injury related to this issue.
Affected products
A. COULTER BODY FLUID CONTROL KIT, LEVEL 1
Lot or serial number
>10 NUMBERS, CONTACT MFG
Model or catalog number
- 628030
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES