FDA Device

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

Hazard

Reports of false negative results on Sysmex Coagulation System.

What You Should Do

Remedy

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.

Products

Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Brand
Dade Behring Inc.
UPC
Catalog number OQWM

Units Affected

2987 units