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Terminated

Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0801-03 · Posted 2003-05-09

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeLOM
Date Initiated2003-04-07
Date Terminated2003-08-19
Product Quantity289 kits

Reason for Recall

Particulate matter in the microparticle component.

Firm Action

Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining.

Root Cause

Other

Distribution Pattern

Canada, Germany and Japan

Official Source

View FDA Recall →

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

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