AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
FDA device recall Z-0240-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Reason for recall
- False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDQ
- Quantity affected
- All lots.
- 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
- Date initiated
- 2003-11-24
- Date posted
- 2003-12-18
- Date terminated
- 2012-01-25
- Location
- South Pasadena, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.