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Access IL-6 Calibrators (2015-10-05)
- Starting date:
- October 5, 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-55640
Affected Products
A. Access IL-6 Calibrators
B. Access IL-6 Calibrators
C. Access IL-6 Calibrators
Reason
Beckman Coulter has determined through internal testing that access IL-6 Calibrator Lot 217782 has failed to meet its stability specifications and expiration dating. Access IL-6 Calibrator Lot 217782 may generate falsely elevated patient sample and quality control results across the reportable assay range. Based on internal testing, the customer may experience patient sample and quality control results approximately 15% higher than the corresponding values observed in baseline testing against this calibrator lot.
The issue was discovered through internal testing in April 2015. There has been no report of death or injury related to this issue.
Affected products
A. Access IL-6 Calibrators
Lot or serial number
217782
Model or catalog number
A16370
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
B. Access IL-6 Calibrators
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
C. Access IL-6 Calibrators
Lot or serial number
217782
Model or catalog number
A16370
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES