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Terminated

The MDA system with MDA Antithrombin III MDA Heparin

FDA Recall Z-0043-05 · Posted 2004-10-23

Recalling FirmbioMerieux
Recall StatusTerminated
Product CodeJPA
Date Initiated2004-06-11
Date Terminated2005-06-07

Reason for Recall

The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.

Firm Action

Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK

Official Source

View FDA Recall →

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

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