This page has been archived on the Web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 LH SERIES DILUENT (2015-07-20)
- Starting date:
- July 20, 2015
- Posting date:
- August 11, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54590
Affected Products
A. COULTER LH SERIES DILUENT
Reason
Beckman coulter has received an increased number of complaints related to the hemoglobin (HGB) parameter on the LH 750 and LH 780 analyzers, including: HGB background failures, HGB incomplete computations (...), and one customer observed false low HGB values.
The investigation revealed that the issues may be related to variability in a component of the diluents, which in turn may lead to a film coating the inside of the HGB cuvette. The issue is not observed with all analyzers.
Affected products
A. COULTER LH SERIES DILUENT
Lot or serial number
510376F - 510657F
Model or catalog number
8547194
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES