Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- August 27, 2004
- Posted
- September 30, 2004
- Terminated
- July 29, 2005
- Recall Number
- Z-1498-04
- Quantity
- 6,691 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
Distribution
Canada, Japan, Australia, New Zealand, Germany and England
Lot / Code Info
list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100
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 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens and were instructed to discontinue use and destroy any of the affected lots remaining.