This page has been archived on the Web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.
Unicel DxC SYNCHRON ACCESS INTEGRATED Clinical Systems (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 III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54586
Affected Products
- UniCel DxC 600 SYNCHRON Clinical Systems
- UniCel DxC 800 SYNCHRON Clinical Systems
- UniCel DxC 600i SYNCHRON ACCESS INTEGRATED Clinical Systems
- UniCel DxC 880i SYNCHRON ACCESS INTEGRATED Clinical Systems
- Unicel DxC 660i SYNCHRON ACCESS INTEGRATED Clinical Systems
- UniCel DxC 860i SYNCHRON ACCESS INTEGRATED Clinical Systems
Reason
Beckman Coulter has identified a failure of the UniCel DxC ISE Tubing (lines 11, 25 and 26) for ISE reference reagent. The failure occurs due to the interaction between a new tubing plasticizer and the ISE reference reagent. The supplier's change in plasticizer was a result of a move to a phthalate-free tubing material based on new environmental regulations. As a result, a slow forming non-microbial white material may appear inside the tubing. Observed symptoms of the presence of the white material can include suppressed ion specific electrode (ISE) quality control and patient results, ISE calibration failures, and detached tubing lines 25 or 26 due to obstruction of flow. Current investigation suggests it is highly unlikely that incorrect results will be generated.
Affected products
A. UniCel DxC 600 SYNCHRON Clinical Systems
Lot or serial number
>10 numbers, contact mfg.
Model or catalog number
- 4764
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
B. UniCel DxC 800 SYNCHRON Clinical Systems
Lot or serial number
>10 numbers, contact mfg.
Model or catalog number
- 4764
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
C. UniCel DxC 600i SYNCHRON ACCESS INTEGRATED Clinical Systems
Lot or serial number
>10 numbers, contact mfg
Model or catalog number
- 4767
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
D.UniCel DxC 880i SYNCHRON ACCESS INTEGRATED Clinical Systems
Lot or serial number
- 2788
- 3563
- 4143
Model or catalog number
- 4768
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
E. Unicel DxC 660i SYNCHRON ACCESS INTEGRATED Clinical Systems
Lot or serial number
- 4036
Model or catalog number
- 4771
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES
F. UniCel DxC 860i SYNCHRON ACCESS INTEGRATED Clinical Systems
Lot or serial number
- 3048
- 4282
Model or catalog number
- 4773
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES