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Aeroset System – Phenobarbital Reagent
- Starting date:
- November 20, 2012
- Posting date:
- December 24, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-25891
Recalled Products
- Aeroset System – Phenobarbital Reagent
Reason
Abbott Diagnostics is recalling clinical chemistry phenobarbital reagent lots 62299un12 and 85773un12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the phenobarbital assay is less than or equal to 7% total cv%, however, internal testing confirmed cvs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803un12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.
Affected products
A. Aeroset System – Phenobarbital Reagent
Lot or serial number
52803UN12, 62299UN12, 85773UN12
Model or catalog number
1E08-01
Companies
- Manufacturer
- Abbott Laboratories Diagnostic Division