Z-0172-06

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

Name: Z-0172-06 Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method
Creator: Dade Behring , Inc.
Published: 2005-07-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-07-29 / Terminated

FDA source

Dade Behring , Inc. began a recall of Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method on 2005-07-29. The reason FDA records is "Reports of false negative results on Sysmex Coagulation System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0172-06
Status: Terminated
Initiated: 2005-07-29
Posted: 2005-11-18
Terminated: 2006-03-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Reason for recall: Reports of false negative results on Sysmex Coagulation System.
FDA root cause: Other
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.
Quantity in commerce: 2987 units
Distribution: The product was shipped to medical facilities nationwide.
Product codes and lots: Catalog number OQWM

Product code DAP

K041438Class IIAdvanced D-Dimer AssayDade Behring, Inc. / cleared 2004-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)