Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division
FDA device recall Z-0209-04 · posted 2003-12-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOM
- Quantity affected
- 2,244 kits
- Distribution
- Canada, Japan, Australia, New Zealand, Germany and England
- Date initiated
- 2003-11-05
- Date posted
- 2003-12-11
- Date terminated
- 2004-07-20
- Location
- Abbott Park, IL
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