Recall Z-0769-04 ยท CDO Acid, Uric, Uricase (U.V.)
Abbott Laboratories Diagnostic Div
Clinical Chemistry Uric Acid; LN 7D76-20
| Date | Jul 20, 2004 (initiated Mar 18, 2004) |
| Status | Terminated |
| Reason | Unacceptable upward drift of results in control runs within 24 hour period. |
| Root cause | Other |
| Action | 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. |
| Quantity | 796 kits. |
| Distribution | Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.