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Terminated

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

FDA Recall Z-1498-04 · Posted 2004-09-30

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeLOM
Date Initiated2004-08-27
Date Terminated2005-07-29
Product Quantity6,691 kits

Reason for Recall

There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

Firm Action

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.

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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