This page has been archived on the Web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.
DURACLONE B27 REAGENT KIT (2017-12-11)
- Starting date:
- December 11, 2017
- Posting date:
- December 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65498
Affected products
DURACLONE B27 REAGENT KIT
Reason
As a result of internal investigations, Beckman Coulter has determined that the affected Duraclone B27 reagent lot number has a defect that may generate false negative results in some samples.
Affected products
DURACLONE B27 REAGENT KIT
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
B36862
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES