Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued December 11, 2003).
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- November 5, 2003
- Posted
- December 11, 2003
- Terminated
- July 20, 2004
- Recall Number
- Z-0209-04
- Quantity
- 2,244 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
Distribution
Canada, Japan, Australia, New Zealand, Germany and England
Lot / Code Info
List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004; and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004
Root Cause
Other
Action Taken
Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 11/5/03 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the aspiration errors in the conjugate component and were instructed to discontinue use and destroy any of the affected lots remaining.