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Access HLH Calibrators (Access System)
- Starting date:
- November 5, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16335
Recalled Products
- Access HLH Calibrators (Access System)
- Access HLH Calibrators (Unicel DXI 600)
- Access HLH Calibrators (Unicel DXI 800)
Reason
The affected lots do not meet the stated expiration date claim. As a result, the quality control and patient sample results generated while using the affected lot numbers might be falsely elevated by as much as 13%.
Affected products
A. Access HLH Calibrators (Access System)
Lot or serial number
008546, 011895, 014099, 022519, 109784, 113689, 118299, 122157, 220438, 916872
Model or catalog number
33515
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Access HLH Calibrators (Unicel DXI 600)
Lot or serial number
008546, 011895, 014099, 022519, 109784, 113689, 118299, 122157, 220438,
916872
Model or catalog number
33515
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Access HLH Calibrators (Unicel DXI 800)
Lot or serial number
008546, 011895, 014099, 022519, 109784, 113689, 118299, 122157, 220438,
916872
Model or catalog number
33515
Companies
- Manufacturer
- Beckman Coulter Inc.