UniCel DxC 600, 600i, 800, 800i, 860i, 880i (2018-10-29)
- Starting date:
- October 29, 2018
- Posting date:
- February 15, 2019
- 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-69026
Affected Products
- A. UniCel DxC 600
- B. UniCel DxC 800
- C. UniCel DxC 600i
- D. UniCel DxC 880i (Part of DxC 800i integrated system)
- E. UniCel DxC 860i (Part of DxC 800i integrated system)
Reason
Beckman Coulter has confirmed that chloride electrode tips from Lots 1822 and 1827 may fail calibration span.
- Calibration span may recover
-
Calibration span may recover within acceptable span values and pass calibration but the chloride electrode tip may have a shorter than expected life.
2000>
Affected products
A. UniCel DxC 600
Lot or serial number
ELECTRODE TIP LOTS 1822 & 1827
Model or catalog number
4764
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
B. UniCel DxC 800
Lot or serial number
ELECTRODE TIP LOTS 1822 & 1827
Model or catalog number
4764
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
C. UniCel DxC 600i
Lot or serial number
ELECTRODE TIP LOTS 1822 & 1827
Model or catalog number
4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
D. UniCel DxC 880i (Part of DxC 800i integrated system)
Lot or serial number
ELECTRODE TIP LOTS 1822 & 1827
Model or catalog number
4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES
E. UniCel DxC 860i (Part of DxC 800i integrated system)
Lot or serial number
ELECTRODE TIP LOTS 1822 & 1827
Model or catalog number
4767
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea, California
92821
UNITED STATES