Dade Behring Inc. Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Brand
Dade Behring Inc.
Lot Codes / Batch Numbers
Catalog number OQWM
Products Sold
Catalog number OQWM
Dade Behring Inc. is recalling Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. due to Reports of false negative results on Sysmex Coagulation System.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of false negative results on Sysmex Coagulation System.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026