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.
Affected by this recall?
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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