Recall Z-0240-04 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Abbott Laboratories Diagnostic Div
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
| Date | Dec 18, 2003 (initiated Nov 24, 2003) |
| Status | Terminated |
| Reason | False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.