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Terminated

American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

FDA Recall Z-0779-2007 · Posted 2007-05-03

Recalling FirmAmerican Diagnostica, Inc.
Recall StatusTerminated
Product CodeGIR
Date Initiated2007-02-28
Date Terminated2016-07-06
Product Quantity249 kits

Reason for Recall

Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

Firm Action

American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052124ACTICLOT, MODEL 824American Diagnostica, Inc. · 2005-10-17

Official Source

View FDA Recall →

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

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