Recall Z-0279-04 ยท LEH Radioimmunoassay, Vancomycin
Abbott Laboratories HPD/ADD/GPRD
Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
| Date | Jul 20, 2004 (initiated Nov 17, 2003) |
| Status | Terminated |
| Reason | The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges |
| Root cause | Other |
| Action | Field Correction recall by undated letter sent on 11/17/03 to all customers receiving the affected lots of reagents. The accounts were informed of the incorrect values for the alternate unit (mol/L) Control Ranges 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 use the correct values listed in the table for the assays. The letters also listed the package insert item numbers for the updated inserts being used in current reagent production. |
| Quantity | 5,603 kits |
| Distribution | Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900940 | TDX PHENCYCLIDINE II ASSAY Abbott Laboratories, Apr 25, 1990 |