Abbott Laboratories HPD/ADD/GPRD ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
All lots with insert version 69-5997/R4. The corrected insert is version 69-6506/R5.
Products Sold
All lots with insert version 69-5997/R4. The corrected insert is version 69-6506/R5.
Abbott Laboratories HPD/ADD/GPRD is recalling ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 due to The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026