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Terminated

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

FDA Recall Z-0209-04 · Posted 2003-12-11

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeLOM
Date Initiated2003-11-05
Date Terminated2004-07-20
Product Quantity2,244 kits

Reason for Recall

Aspiration errors in the conjugate component due to microbial contamination of the conjugate.

Firm Action

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

Distribution Pattern

Canada, Japan, Australia, New Zealand, Germany and England

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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