Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
This recall has been terminated (originally issued November 18, 2005).
- Company
- Dade Behring Inc.
- Recall Initiated
- July 29, 2005
- Posted
- November 18, 2005
- Terminated
- March 1, 2006
- Recall Number
- Z-0172-06
- Quantity
- 2987 units
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of false negative results on Sysmex Coagulation System.
Distribution
The product was shipped to medical facilities nationwide.
Lot / Code Info
Catalog number OQWM
Root Cause
Other
Action Taken
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.
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