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Synchron and UniCel products
- Starting date:
- December 12, 2012
- Posting date:
- December 16, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Hospitals, Healthcare Professionals
- Identification number:
- RA-16253
Recalled Products
- Synchron LX20
- Unicel DXC 600
- Unicel DXC 800
- UnicelDXI 600I
- Unicel DXI 880I
- Synchron CX4 Pro
- Synchron CX5 Pro
- Synchron CX9 Pro
- Synchron LXI725
- Synchron LX20 Pro
- Unicel DXC 660I
- Unicel DXC 860I
Reason
Beckman Coulter has determined that the "observed effect" of the bilirubin interference listed in the hemoglobin index interferences table and the values in the hemoglobin index data table of the chemistry reference manual (Doc# A45586) are not accurate based on current Beckman Coulter practices for establishing these values.
Affected products
A. Synchron LX20
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
441350
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Unicel DXC 600
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
4764
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Unicel DXC 800
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
4764
Companies
- Manufacturer
- Beckman Coulter Inc.
D. Unicel DXI 600l
Lot or serial number
More than 10 Numbers, contact manufacturer.
Model or catalog number
4767
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
Companies
- Manufacturer
- Beckman Coulter Inc.
Product
Lot or serial number
More than 10 Numbers, contact manufacturer.
E. Unicel DXl 880l
Lot or serial number
More than 10 numbers, contact manufactuer.
Model or catalog number
4768
Companies
- Manufacturer
- Beckman Coulter Inc.
F. Synchron CX4 Pro
Lot or serial number
More than 10 numbers, contact manufacturer,
Model or catalog number
468200
Companies
- Manufacturer
- Beckman Coulter Inc.
G. Synchron CX5 Pro
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
468202
Companies
- Manufacturer
- Beckman Coulter Inc.
H. Synchron CX9 Pro
Lot or serial number
More than 10 numbers, contact manufacturers.
Model or catalog number
473541
Companies
- Manufacturer
- Beckman Coulter Inc.
I. Synchron LXl725
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
476501
Companies
- Manufacturer
- Beckman Coulter Inc.
J. Synchron LX20 Pro
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
476100
Companies
- Manufacturer
- Beckman Coulter Inc.
K. Unicel DXC 660l
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4771
Companies
- Manufacturer
- Beckman Coulter Inc.
L. Unicel DXC 860l
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4773
Companies
- Manufacturer
- Beckman Coulter Inc.