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Access System sTfR assay
- Starting date:
- October 11, 2016
- 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-60700
Affected Products
Depth of distribution
During an internal review, Beckman Coulter determined that the following global harmonized system hazard classification warnings and European hazard classification warnings for Reagent Well R1B are missing from the current access soluble transferrin receptor (sTfR) instructions for use (IFU) versions.
Affected products
Access System sTfR assay
Lot or serial number
530149
532640
Model or catalog number
A32493
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES