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Terminated

Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100

FDA Recall Z-0304-06 · Posted 2005-12-23

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeGGW
Date Initiated2005-09-23
Date Terminated2006-05-11
Product Quantity4176 packs

Reason for Recall

prolonged aPTT results

Firm Action

The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities and/or laboratories nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811589ACTIN FS ACTIVATED PTT REAGENTAmerican Dade · 1981-07-16

Official Source

View FDA Recall →

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

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