Clinical Chemistry Uric Acid; LN 7D76-20
FDA device recall Z-0769-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Reason for recall
- Unacceptable upward drift of results in control runs within 24 hour period.
- Action taken
- Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDO
- Quantity affected
- 796 kits.
- Distribution
- Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.
- Date initiated
- 2004-03-18
- Date posted
- 2004-07-20
- Date terminated
- 2012-02-10
- Location
- South Pasadena, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.