AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
This recall has been terminated (originally issued December 18, 2003).
- Recall Initiated
- November 24, 2003
- Posted
- December 18, 2003
- Terminated
- January 25, 2012
- Recall Number
- Z-0240-04
- Quantity
- All lots.
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
Distribution
Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas
Lot / Code Info
All lots.
Root Cause
Other
Action Taken
Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.
More recalls by Abbott Laboratories Diagnostic Div
Clinical Chemistry Prealbumin, List Number 1E02-20
Jan 11, 2006