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
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- November 17, 2003
- Posted
- July 20, 2004
- Terminated
- November 1, 2004
- Recall Number
- Z-0279-04
- Quantity
- 5,603 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges
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, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
Lot / Code Info
Reagent List 9500-60, lots 03136Q100, 92723Q102, 92723Q101, 92723Q100; and Reagent List 9500-85, lots 02285Q100, 92724Q100 that contain insert item number 69-5162/R4
Root Cause
Other
Action Taken
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.