Recall Z-0507-04 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Abbott Laboratories HPD/ADD/GPRD
TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
| Date | Feb 4, 2004 (initiated Dec 5, 2003) |
| Status | Terminated |
| Reason | The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table |
| Root cause | Other |
| Action | Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory. |
| Quantity | 1,644 kits |
| Distribution | Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854542 | TDX C-REACTIVE PROTEIN Abbott Laboratories, Jan 24, 1986 |