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Terminated

Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.

FDA Recall Z-0172-06 · Posted 2005-11-18

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeDAP
Date Initiated2005-07-29
Date Terminated2006-03-01
Product Quantity2987 units

Reason for Recall

Reports of false negative results on Sysmex Coagulation System.

Firm Action

On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041438ADVANCED D-DIMER ASSAYDade Behring, Inc. · 2004-08-11

Official Source

View FDA Recall →

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

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