Abbott Laboratories Diagnostic Div
Clinical Chemistry Urea Nitrogen
| Date | Feb 26, 2004 (initiated Nov 24, 2003) |
| Status | Terminated |
| Reason | Low results due to contaminant. |
| Root cause | Other |
| Action | Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed. |
| Quantity | 568 |
| Distribution | Nationwide, Mexico, Argentina, Germany, Australia, Venezuela, Puerto Rico, Singapore, New Zealand, Columbia, Canada, Hong Kong, Grand Cayman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.