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Urea Nitrogen (for the AU 480 / AU 680 Analyzers Only)
- Starting date:
- October 31, 2011
- Posting date:
- April 2, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-26273
Recalled Products
- Urea Nitrogen (for the AU 480 / AU 680 Analyzers Only)
Reason
Some customers may see an increase in calibration factor for urea nitrogen reagent osr6134 and osr6234 on the au480/au680 analyzers, which in turn may lead to calibration failures that could delay quality control or patient sample analysis.
Affected products
A. Urea Nitrogen (for the AU 480 / AU 680 Analyzers Only)
Lot or serial number
All Lots
Model or catalog number
- OSR6134
- OSR6234
Companies
- Manufacturer
- Beckman Coulter, Inc.